Maetrics Assists Manufacturers with Medical Device Directive Compliance

Maetrics is currently assisting multiple world-class medical device manufacturers as they transition their operations to meet the new regulatory requirements enacted through MDD 2007/47/EC (M5). 

Here is a listing of some of Maetrics' key capabilities related to successfully obtaining CE Marking and compliance with MDD 2007/47/EC requirements:

• Consultants trained to M5 regulations including MDD 2007/47/EC revisions to MDD 93/42/EEC as well as AIMDD 90/385/EEC
• Experienced auditors who have led 100s of assessments & audits involved in achieving both ISO certifications as well as CE markings
• Implementation of entire Quality Management Systems through M2 Program Management Methodologies
• Comprehensive expertise surrounding all classes of medical devices & their corresponding requirements
• IRCA Lead Auditors
• Understanding of Harmonized Standards & Guidance Documents

Find out more about our experience with CE Marking and how we can help you. 

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