CE Mark Approval
The CE marking (also known as CE mark) is a mandatory conformance mark on many products placed on the single market in the European Economic Area (EEA). The CE marking certifies that a product has met requirements of the applicable European Medical device derivative like active implantable medical device (AIMD) Directive 90/385/EEC and medical device Directive 93/42/EEC and its further modifications.
MDR Technical Documentation / Gap Analysis
Our expert’s review device design, risk analysis, clinical evaluation, testing reports, post-market surveillance, labeling, and other required areas. Gap analysis is carried out to ease the transition in the required areas.
Conversion of MDD to MDR File(s)
To meet with the New EU Medical Device Regulation (MDR) in which safety, efficacy, and performance measures are required in technical documentation, many manufacturers with CE Certification under MDD need to convert their documentation to meet the new Medical Device Regulation (MDR). The existing files shall be reviewed and upgraded with quality materials to meet all requirements.
Clinical Documentation - Evaluation Plan & Procedures
Why choose E & E Medicals and Consulting?
Our experts and partners who are EU Authorized Representatives identify hazards, assess risks, carry out all applicable tests to determine the appropriate measures to meet with CE mark approval, CE marking, and CE certification mark regulations.
Our team of medical device consultants helps in transforming existing medical device Files to MDR.