CE Mark Approval
The CE marking (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 the requirements of the applicable European Medical device derivative. Like active implantable medical device (AIMD) Directive 90/385/EEC medical device Directive 93/42/EEC its modifications.
MDR Technical Documentation / Gap Analysis
Our experts review device design, risk analysis, clinical evaluation, testing reports, post-market surveillance, labeling, other required areas. Gap analysis is 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. Many works with CE MDD need to convert their documentation to assemble the new Medical Device Regulation (MDR). The existing files shall upgraded with quality materials to meet all needs.
Clinical Documentation - Evaluation Plan & Procedures
The Clinical Documentation process begins with a clearly designed Evaluation Plan. Which entails the methodological systematic approach to reach adequate reporting. It provides a step-by-step approach to conducting documenting each procedure. In the MDR, Chapter VI, Article 61 critical issues for clinical data. Our experts have developed forms templates for mandatory procedures.
Why choose E & E Medicals and Consulting?
Our experts and partners who live EU Authorized recognize threats, consider dangers. Carry out all applicable tests to determine the appropriate measures to meet with CE mark approval, CE marking, CE certification mark regulations. Our team of medical device consultants helps in transforming existing medical device Files to MDR. The EU necessities may consist of protection, fitness, environmental protection. Many merchandises require CE marking they are within the EU.