Maetrics appoints Dr. Amie Smirthwaite to lead Clinical Practice
May 2020 – Maetrics, an international leader in life sciences quality and regulatory consulting, has appointed Dr Amie Smirthwaite as Senior Director of the Global Clinical Practice. A clinical and regulatory affairs expert, Amie has over 25 years’ postdoctoral experience in medical devices, spanning new product development, quality and regulatory systems and clinical data evaluation. She will be leading the company’s global clinical practice discipline which is dedicated to delivering effective clinical and performance evidence and post-market surveillance for international medical device and IVD regulatory compliance.
Prior to joining Maetrics, Amie was the Global Head of Clinical Compliance at BSI Notified Body, having been with the organization for 12 years. Amie developed BSI’s clinical compliance team in response to emerging requirements from Commission Implementing Regulation 2013/920 and the publication of the EU Medical Device Regulation. She was a member of the team spearheading the organization’s successful submission to achieve EU MDR designation. She has been an active member of European Commission Working Groups for clinical evaluation and post-market surveillance, representing Team NB and NBMed.
Amie is also a member of standards committees and key policy initiatives including: MHRA’s Beyond Compliance steering group; the Network of Orthopaedic Registries of Europe; and the ISO Technical Committees for surgical implants and for biological and clinical evaluation of medical devices.
The Clinical Practice at Maetrics was developed in response to the growing regulatory and quality requirements for clinical and performance evidence. Maetrics offers a managed service which oversees and maintains the entire life cycle of clinical and performance data across the critical regulatory and quality updates and inputs that are required, including: pre-market, post-market surveillance, risk management, tech file updates, notified body reviews.
Steve Cottrell, President at Maetrics, comments: “With increasing pressure on regulatory teams to meet new and growing requirements for clinical and performance reporting, finding a partner that delivers effective clinical compliance services is now critical for manufacturers who want to focus on their organizational goals and deliver business success in the long-run. We are delighted to welcome Amie to the Maetrics team. Her hands on Notified Body experience and the EU MDR expertise she brings means that Maetrics will continue to lead the charge in its clinical managed services.”
Amie adds: “I am thrilled to be starting this new journey with Maetrics, and to lead such a high-calibre team in the Clinical Practice. With an additional year to work on EU MDR compliance and two years to go until the EU IVDR deadline, we are dedicated to supporting life science companies as they navigate uncharted waters.”[more]
MDR Extension: Key Takeaways
You may have heard the EU Medical Device Regulation (EU MDR) date of application is being delayed one year, but might be wondering what it really means. For some this is welcome news and allows more time to get ready, for others it doesn’t change much. The vote to delay was approved by an overwhelming margin on April 17, 2020 and the amendment was published in the Official Journal of the European Union on April 23, 2020.
This delay of the EU MDR date of application comes as a positive development for our industry during these unprecedented times. The new date of May 26, 2021 has been established by the European Parliament and Council in an amendment to the original regulation. This also means the repeal of the Medical Device Directives (90/385/EEC and 93/42/EEC) is delayed by one year.
The following are key takeaways regarding the details from the amendment:
- This only applies to the Medical Device Regulation. There is no change to the In Vitro Diagnostic Regulation (2017/746).
- The regulatory requirements of the regulation itself have not been amended. The requirements remain the same for Medical Device Manufacturers, Notified Bodies, Authorized Representatives, Importers and Distributors.
- There are no changes to the transition dates for CE Mark certificates under the previous EU Medical Device Directive. The Medical Device Directive certificates will still expire no later than May 26, 2024, and devices in service or already on the market as of May 26, 2021 may continue to be made available until May 26, 2025.
- There are updates to Article 59, Derogations from the conformity assessment procedures. This pertains to exceptions to the rules for conformity assessments that allow non-CE marked products deemed of ‘humanitarian use’ to be used for the good of public health. The amendment also now specifically references the corresponding Articles in the MDD (Article 11.13) and AIMD (Article 9.9). By including these references to the directives, the derogations adopted under the directives may apply or be extended using Implementing Acts once the May 26, 2021 date of application is reached.
- There are updates to Article 120, Transitional provisions. The amendment now includes Class I devices with declaration of conformity prior to May 26, 2021, and for which an assessment to the EU MDR requirements would require a notified body. The transition dates remain the same, but now clearly includes these Class I devices, aligned with guidance previously published by the Medical Device Coordination Group (MDCG).
- Article 122, Repeal, has been updated to align the repeal of the directives with the date of application of the new EU MDR.
- Article 123, Entry into force and date of application, introduces new staggered implementation dates for Unique Device Identification (UDI). Specifically, for reusable devices which bear the UDI carrier on the device itself, the new dates are as follows: May 26, 2023 for implantable devices and class III devices; May 26, 2025 for class IIa and class IIb devices; May 26, 2027 for class I devices.
There is some confusion about the impact of the delay in the Date of Application with the already announced delay in the implementation of the Eudamed database. Article 34, which pertains to the Functionality of Eudamed, has been updated to reference the May 26, 2021 date. However, the date in Article 34 is not necessarily the date by which Eudamed is required to be functional. Unless further guidance is provided by the MDCG, the implementation of Eudamed is still expected in May, 2022, as previously announced. This corresponds with the implementation date of the EU IVDR.
With these changes comes a significant opportunity for manufacturers to use this time wisely and not take their foot off the gas when it comes to EU MDR preparedness. Being ready for quality and regulatory compliance will give companies an edge over their competitors and reduce the risk of products being taken off the market. Many companies were struggling to fully meet the deadline and will be able to use the additional time to be truly ready.
At Maetrics, we are successfully supporting clients with effective remote teams as they prepare to meet the EU MDR requirements. We partner with companies to thoroughly assess and remediate their technical documentation and quality management systems. The EU MDR has increased requirements for Clinical Evaluations and other Technical File documentation, which now also includes new Post Market Surveillance documentation. The additional time can also be used to properly evaluate and confirm Economic Operator relationships and agreements. The clarification in UDI timelines also allows for more robust planning and implementation.
Contact us if you have questions about the EU MDR requirements, this new update or your compliance planning.[more]
BE > TOGETHER
Maetrics is committed to partnering with our clients to deliver critical supplies and services during this global pandemic. Our priority remains safeguarding our employees, clients and communities, while continuing to deliver the compliance support that is needed.
At the beginning of each year we develop a core message to motivate and guide our efforts. Our theme for 2020 is BE > TOGETHER. When we developed this message, little did we know how relevant this theme would become as we work together with our clients to manage through this pandemic gripping the world.
Maetrics remains committed to our support of the life science industry. We can help you tackle any short term needs or strategic initiatives, allowing your teams to focus on the task at hand. Our experienced teams can offer remote support in all aspects of our service offering, however given the current unique situation we highlight the following easily remotely implemented solutions:
- Clinical and Performance Evaluation Reporting
- Remote Auditing Solutions
- Technical Documentation Review and Remediation
- R&D Solutions: new product regulatory and quality strategy and compliance road mapping.
At Maetrics our ethos is to be a flexible, trusted and reliable partner to clients. We are aware that the industry we work in is critical to supporting the fight against COVID-19 across the world. Thank you to you and your teams for all you are doing in this time to support patients and those serving in the front line. We stand shoulder to shoulder with you.
We wish you a safe and healthy week ahead and hope you reach out with anything you need during this time.
Unprecedented regulatory shift for Economic Operators
Maetrics, a leading international life sciences regulatory and compliance consultancy, has launched a whitepaper explaining the new (and changed) responsibilities for Economic Operators required by the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR). The whitepaper looks at the changes in regulations concerning all four Economic Operator entities, highlighting the impact on Importers and Distributors as they face entirely new requirements.
All Manufacturers will have to identify and confirm compliance of their Economic Operators by Date of Application for the EU MDR (26th May 2020). Failure to do so may cause serious ramifications further down their supply chains. The whitepaper aims to draw attention to the fact that three out of four Economic Operators are now legally and severally liable for devices sold on the market. This is an unprecedented change in regulation, with potential serious consequences for those entities involved if compliance is not achieved; in particular legal action and loss of market access.
To read the press release in full, click here.
The full whitepaper is available to download here.[more]
The Clock Is Ticking
The Countdown to EU IVDR/MDR Compliance Has Begun
May 2019 – Maetrics, a leading international life sciences regulatory and compliance consultancy, has launched a new whitepaper highlighting the critical importance for Class I medical device manufacturers to comply with the EU Medical Device Regulation (MDR). The MDR transition period ends on May 26th 2020 at which point any non-compliant manufacturers will be restricted from selling and distributing their products on the EU market.
This new whitepaper has been created to serve as a valuable tool for Class I medical device manufacturers to help ensure they maintain EU market access. The aim of the whitepaper is to raise awareness of the pressing issue of dealing with reclassification and achieving timely compliance under the MDR, providing guidance and practical steps that Class I manufacturers should take as soon as possible. To read the full press release, click here. To download the whitepaper, click here.[more]
Maetrics appoints Elizma Parry to lead Clinical Practice
January 2019 – Maetrics, a global leader in life sciences consulting, has appointed Elizma Parry to Director of the Global Clinical Practice. A highly qualified industry professional, Elizma is a proven leader with a strong track record of clinical safety, regulatory and quality management experience. She is leading the company’s clinical practice which is dedicated to delivering effective clinical and performance evidence for international medical device and IVD regulatory compliance.
Elizma brings over 25 years of experience to the Maetrics team. Having recently been in a shared acting role as the Head of a Europe-based Notified Body before joining Maetrics, Elizma was also managing a multi-national clinical team within the Notified Body that was responsible for the clinical safety, performance and clinical benefit conformity assessments of medical device manufacturers’ clinical evidence, as well as the clinical lead for liaising with the MHRA. Elizma will provide Maetrics’ clients with expert counsel in the Clinical Practice environment.
Elizma has also worked across quality, regulatory and biotechnology environments throughout her career. She has developed and presented training courses across the UK and USA, including joint development of a bespoke Cranfield University course for Notified Body clinical assessors.
Steve Cottrell, President at Maetrics, comments: “We are thrilled that Elizma is joining the Maetrics management team. Elizma’s talent and experience combined with Maetrics’ specialist offering in international medical device and IVD regulatory compliance, means that life science companies can trust Maetrics to deliver the right clinical solutions, guidance and support to maintain their products in the European and global markets.”
Elizma adds: “I am extremely excited to start this new adventure with Maetrics. Our Clinical Practice team is here to help the Medical Device and In-vitro diagnostic industries tackle clinical requirements head on. The team and I are looking forward to supporting life science companies with a fresh and strategic perspective on clinical and performance evidence.”[more]
New Year, New European Offices
Maetrics is excited to announce that we are moving to new offices in Nottingham (UK). As the company continues to grow, we remain dedicated to serving our clients and supporting the life science industry with compliance solutions driven by the knowledge, experience and objectivity of our Solutions Delivery team.
Effective December 20th 2018 our new address will be:
86-88 Mansfield Road
United Kingdom (UK)
Steve Cottrell, President at Maetrics explains: “We continue to invest in our people, the experts who drive our business and serve our clients so diligently. In 2018 we were excited to welcome several new team members, all with significant experience from industry and notified bodies, which has driven a need for more space. We are pleased to have created a fantastic new environment in Nottingham as our European hub of operations.”
We look forward to welcoming clients, team members and partners to our new location!
Maetrics brings EU Medical Device Regulation expertise to the 2018 American Medical Device Summit
Peter Rose, Managing Director for Maetrics in Europe will be speaking about the new Medical Device Regulation (MDR) in Europe at the upcoming American Medical Device Summit at the Westin Lombard Yorktown Center, Lombard, IL, on 25 October at 12:35PM.
To learn more about AMDS or to register, click here.
To read our whitepaper on MDR compliance strategies and how Maetrics can help your organization overcome the significant business challenges that the new Medical Device Regulation presents for bringing products to market in Europe, click here.[more]
A culture of quality called for in pharmaceutical manufacturing
With the rise of federal regulations and scrutiny for the life science industry, there is now a greater awareness of the risks and weak links that have developed in the quality management parts of leading pharmaceutical organizations. Maetrics, a leading international life science regulatory and compliance consultancy, believes the pharmaceutical industry should consider improving the culture of quality to help safeguard patients and drive efficiency in their businesses and has published a white paper to open up dialogue in the industry on this important subject.
In particular, this latest guide from Maetrics looks at:
• Specific examples of how pharmaceutical companies are failing to meet regulatory requirements;
• The pressures social media is placing on the industry;
• The effect of mergers & acquisitions on the global pharmaceutical sector;
• The most common quality deficiencies;
• Suggestions for businesses to follow in order to mitigate risk and deliver high business efficiencies.
To download the whitepaper and find out how Maetrics can help you adhere to the highest CGMP standards, implement a realistic and actionable auditing strategy and address risk in in order to continually grow your business, click here.[more]
Preparing for the new In Vitro Diagnostic Regulation (IVDR) in Europe
Maetrics, the global consultancy firm that provides regulatory, quality, and compliance solutions to the life sciences sector, has published a free step-by-step whitepaper to help manufacturers understand the imminent changes and how to comply with the new IVDR that repeals Directive 98/79/EC as well as Commission Decision 2010/227/EU. To get a real handle on the major changes that the new IVDR brings and the practical implications for manufacturers and distributors of IVD products, click here.[more]
Seizing the MDR Compliance Opportunity
Maetrics, the global consultancy firm that provides regulatory, quality, and compliance solutions to the life sciences sector, today publishes new research quantifying the competitive advantage that medical device manufacturers can seize by moving quickly to comply with the new European Medical Device Regulation (MDR). Across the EU’s ten largest economies plus Switzerland, the Market Opportunity Value for compliance pioneers is estimated to be $16.469 billion. To read our research paper detailing the financial advantages of early adoption, click here.[more]
Maetrics at Medica 2017
Maetrics, the global consultancy firm that provides regulatory, quality, and compliance solutions to the life sciences sector, will attend next month’s Medica trade fair in Düsseldorf (13-16 November 2017).
The company will exhibit on Stand F18-5, Hall 16 and will have senior executives available to share their experience and expertise in regulatory affairs in the medical devices sector. To coincide with the event, Maetrics will also launch a new research whitepaper on the European Medical Device Regulation (MDR), which officially came into effect in May this year and represents the single largest change to medical device regulations in Europe since CE Marking was introduced in 1993.
To schedule a consultation with Maetrics staff at Medica, click here.[more]
Maetrics Appoints Brian Moan to European Solutions Delivery Team
UK (September 04, 2017) – Maetrics, a global leader in life science consulting, has appointed Brian Moan to Director of Solutions Delivery in Europe. A highly qualified industry expert and thought leader specializing in Human Factors, Brian has been involved in MHRA working groups to develop industry guidance, has frequently presented around regulatory issues and has developed Medical Device presentations at Cranfield University as part of their MSc Program on Medical Devices.
Peter Rose to speak on new MDR at RAPS Regulatory Convergence 2017
Peter Rose, Managing Director for Maetrics operations in Europe, will be speaking at the upcoming RAPS Regulatory Convergence about the new Medical Device Regulation (MDR) in Europe at the National Harbour at the DC Waterfront on Monday 11th September from 3:00PM to 3:45 PM.
Chris Busse joins Maetrics as Vice President, Business Development
Indianapolis (6/15/17) Maetrics, a global management consulting firm providing life science companies with deep quality, compliance, regulatory solutions to the life sciences industry, recently named Chris Busse as Vice President, Business Development. In this role, Chris will be responsible for further developing our presence in the Western United States and managing key client relationships.[more]
Are you ready for the fast approaching compliance date for UDI?
Check out the press release Maetrics just released: Maetrics unveils the current landscape of UDI in the USA and the substantial benefits of early compliance in latest free whitepaper.[more]
Maetrics Division Donates 50 Laptops to Local High School
Indianapolis (5/4/2016) Theoris Group’s Maetrics Division was pleased to donate 50 laptops to Lawrence North High School. Located in Indianapolis, Lawrence North is a Four-Star School with over 2,300 students.[more]
After The Approval: Perfecting Your Postmarket Surveillance
Maetrics’ Senior Manager, Parminder Kalle, highlights the importance of understanding and correctly implementing PMS mechanisms for manufacturers wishing to introduce or maintain distribution of devices in markets with new postmarket requirements.[more]
Maetrics Discusses the ROI of Compliance in Event with ABHI
Maetrics partners with the Association of British Healthcare Industries (ABHI) to host a highly informative seminar on “The ROI of good quality and compliance”. The aim of the seminar was to provide regulatory executives and leaders in the medical device industry a variety of viewpoints on how to successfully integrate quality management and corporate compliance in order to achieve the best Return On Investment (ROI).[more]
Maetrics UK Office Launches New Seminar Series and Publishes its 2016 Training Courses
Maetrics, dedicated to guiding life sciences companies through the challenges related to quality, regulatory, and compliance, recently published its 2016 training courses and newly offered seminars in the UK. Maetrics’ seminars are aimed at C-level executives and directors to inform on topical quality and regulatory issues to ensure their business can appropriately plan, budget, and be prepared for compliance in the ever changing regulated environment. Register online or view our complete 2016 brochure.[more]
Maetrics Promotes Beth Crandall to Managing Director
Indianapolis (2/3/2016) Maetrics, a global management consulting firm providing life science companies with deep quality, compliance, and regulatory solutions, recently promoted Beth Crandall to the role of Managing Director. Ms. Crandall’s duties will expand to leading client engagement strategies and solutions as well as providing technical oversight on managing key client relationships.[more]
Regulatory Outlook – Avoid Form 483 Observations & Warning Letters
An FDA inspection can be nerve-wracking. As published in January’s edition of MDDI magazine (page 24), learn what Maetrics leader Norm Rabin advises you can do in person during an inspection to avoid receiving Form 483 observations or a warning letter.[more]
Maetrics Announces Ed Roach as Managing Director
Indianapolis (1/14/2016) Maetrics, a global management consulting firm providing life science companies with deep quality, compliance, regulatory solutions, recently named Ed Roach as Managing Director. In this role, Mr. Roach will lead engagement strategies and solutions delivery for Maetrics clients as well as provide oversight to managing key client relationships.[more]
Top Maetrics Executive Outlines Common Pitfalls of New FDA UDI Implementation and How to Avoid Them, at BioMed Boston
(Boston, Massachusetts USA) About six months ago, the United States Food and Drug Administration (FDA) released new rules which require most medical devices distributed in the United States to bear a Unique Device Identification, or a UDI. Debara Reese, Vice President, Quality and Compliance, for global life sciences compliance consulting firm, Maetrics, recently spoke at the BioMed Conference in Boston where she explained, “The most common pitfall I’ve seen regarding UDI implementation is underestimating the complexity of the project. This is not just a labeling issue; it involves multiple departments and functions, including suppliers and distributors. It requires time, money and resources.”[more]
European Medical Device Manufacturers Face New Regulations Starting in 2016, According to Top Compliance Consulting Executive
Maetrics’ European Managing Director Outlines The Demands And Costs Of Implementation, At Med-Tech Innovation Expo.[more]
Top Life Sciences Consulting Executive Outlines Effective CAPA Systems at Medical Device Conference in New York Tomorrow
(New York, NY) In the last few years, the fastest growing item cited in FDA warning letters to medical device and pharmaceutical companies is the identification of insufficient CAPA (Corrective and Preventive Action) programs as a source of significant quality system weakness. Debara R. Reese, Vice President, Quality and Compliance, at global life sciences compliance consulting firm, Maetrics, will speak on “Effective CAPA Systems” at MD&M East, at Javits Center in New York on June 10 at 1:20 p.m., one of the largest medical device conferences in the U.S.[more]
Best Practices for Corrective and Preventive Actions (CAPA) Presented by Distinguished Quality and Compliance Executive at Medical Device and Pharmaceutical Leadership Roundtable
(San Diego, California USA) During the last few years, there has been growing attention given by the Food and Drug Administration (FDA) to the implementation of corrective and preventive actions (CAPA) at medical device and pharmaceutical companies. Inspections and actions by the FDA are as concerned about the process for identifying and correcting an issue and making sure it doesn’t happen again, as it is about the issue itself.[more]
Maetrics Announces New President Steve Cottrell to Lead International Life Sciences Consulting Company
Indianapolis – (March 10, 2015) – Maetrics, the global leader in life sciences consulting, today announced that Steve Cottrell, previously vice president of sales, will assume the role of company president.
Cottrell has demonstrated commendable success since joining Maetrics in 2013. Prior to that, Cottrell served in executive positions at DOCS, a division of the global clinical research organization ICON plc; i3 Research, a division of United Health; as well as inVentiv Health and AAI Pharma.[more]
Maetrics Successfully Hosts Conference in Zurich, Switzerland
Zurich – May 28, 2015 – Maetrics, an international leader in life sciences consulting, successfully hosted its first event in Zurich, Switzerland today. The conference, “The Cost of Non-Compliance – How New Regulation is Re-shaping the Medical Technology Industry,” was made available to an exclusive audience of industry executives.[more]
Maetrics Provides Laptops for Outreach Inc. High School Graduates
Indianapolis, Ind. – June 13, 2015 – Maetrics, an international leader in life sciences consulting, recently partnered with Outreach Inc. to provide laptops for a class of 23 high school graduates. Outreach Inc. is a faith-based nonprofit organization that helps homeless teens find stability and transform their lives. The graduates will go on to pursue their studies, work full-time or learn a trade. Read more about the graduates and their post-graduation plans in the Indianapolis Star.[more]
American Medical Device Summit
Chicago, Illinois – September 21st & 22nd, 2015. The American Medical Device Summit sets the standard on how the industry should connect and exchange ideas. This year, Norm Rabin spoke on Global Quality Workflow, outlining a 5-step transition from manual to automated compliance processes. Norm’s full presentation can be found here: SlideShare – Global Quality Workflow – Manual to Automated Compliance Process[more]