Whitepapers

Maetrics is pleased to present recent thinking and information on a wide range of current subjects pertaining to Regulatory Compliance & Quality Solutions.
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CATEGORIES

Medical Device
Pharmaceutical
Biotechnology
Economic Operators

Economic Operators

New responsibilities for Economic Operators
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MDR & Combination Products

MDR & Combination Products

Increasing awareness for combination product manufacturers
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The Clock is Ticking

The Clock is Ticking

Practical steps that Class I Manufacturers should take as soon as possible
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CER 2018

CER 2018

Clinical Evaluation of Medical Devices
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The New EU IVDR

The New EU IVDR

Practical Guidance and Step-by-Step Instructions for Early Adopters
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Market Opportunity Value of MDR

Market Opportunity Value of MDR

Competitive Market Advantage for Compliance Pioneers
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Understanding MDSAP

Understanding MDSAP

Analysis and Practical Guidance
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The New EU MDR

The New EU MDR

Practical Implications for Medical Device Manufacturers
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Software Apps as Medical Device

Software Apps as Medical Device

The Regulatory Landscape
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Contamination Control

Contamination Control

Of Medical Device Cleanrooms
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Risk Management

Risk Management

ISO 14971:2012 Implications for Medical Device Manufacturers
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Post Market Surveillance

Post Market Surveillance

Post Market Surveillance
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Unique Device Identification

Unique Device Identification

Background and Compliance
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Quality Under Scrutiny

Quality Under Scrutiny

Calling for a culture of quality in Pharmaceutical Manufacturing
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Design History File

Design History File

From Inspiration to Reality
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Supply Chain Visibility

Supply Chain Visibility

Created in Partnership with Generis
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Process Validation

Process Validation

A Systematic Approach
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As a dedicated life sciences consulting firm, Maetrics helps enterprises meet the latest compliance standards while attaining business objectives. Our team evaluates client operations, identifies areas for improvement and executes customized solutions.

Maetrics’ hands-on approach ensures that an enterprise’s operations and facilities will have a pathway to compliance success and business growth.

Quick Links
Clinical Evaluation of Medical Devices  read more
A Culture of Quality Called For  read more
The New EU IVDR  read more
Market Opportunity Value of MDR  read more
Understanding the Medical Device Single Audit Program (MDSAP)  read more
The New EU Medical Device Regulation (MDR)  read more
Design History File: From Inspiration to Reality.  read more
Software Apps as Medical Device: Regulatory Landscape.  read more
Contamination Control: Of Medical Device Cleanrooms.  read more
Process Validation.  read more
Calling All Class I Medical Device Manufactures  read more
Connect with us

9000 Keystone Crossing
Suite 230
Indianapolis, IN 46240 USA

Toll free 1-877-623-8742 or 317-706-1493

Maetrics Ltd
Blenheim Court
Huntingdon Street
Nottingham
NG1 3BY
United Kingdom (UK)

Nottingham/Europe HQ +44 115 921 6200

Basel +41 61 511 4930

For questions regarding Maetrics services, please email information@maetrics.com.

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