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]