CE Marking & Compliance with Medical Device Directives
The deadline of March 21st, 2010 for compliance with the new amendments to the European Medical Device Directive as outlined in MDD 2007/47/EC (M5) is rapidly approaching. Numerous medical device manufacturers remain uncertain about the direct impact of these rigorous directives on their products and may be unprepared for the potentially significant amount of work that may be required to achieve compliance. With over 25 years of providing expert services in the Medical Device industry, Maetrics™ offers a suite of services designed to help you rapidly assess and resolve this potentially complex and costly compliance challenge. Do you need help now? Contact Maetrics right away.
Immediate attention is required to ensure your product mix maintains compliance CE Marking requirements. With your company’s share of the $86 billion EU medical device market at stake, it is imperative that you address these impending changes now, or risk potential disruptions in your company’s ability to sell in countries governed by the European Medical Device Directives.
Whether your organization simply needs the reassurance of a simple two-day assessment or the development of a comprehensive plan of action to address these impending changes, Maetrics™ is prepared to ensure that client organizations are confident their CE marked products will pass inspection by Notified Bodies. Depending upon your situation, Maetrics™ is prepared to quickly deploy a team of professionals to implement the changes necessary to comply with the new MDD 2007/47/EC regulations. Through the utilization of proven methodologies and tools, medical device manufacturers can rest assured that their products will maintain compliance with CE Marking requirements, and can thus remain focused on crucial day-to-day operations without interruption.
Here is a sampling of our expertise in disciplines related to CE Marking:
- 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
- Comprehensive expertise surrounding all classes of medical devices & their corresponding requirements including Classes I, IIa, IIb, III, Active Implantables, and In-Vitro Diagnostics
- IRCA Lead Auditors
- Understanding of Harmonized Standards & Guidance Documents
Ready to Get Started? Contact Us Now!
-OR- Take our MDD 2007/47/EC Preparedness Questionaire!
