CE MARK APPROVAL
The CE marking (also known as CE mark approval) 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.
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, CE marking, CE certification mark regulations.
MDR Technical Documentation / GAP analysis
Our team of medical device consultants helps in transforming existing medical device Files to MDR. Our experts 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
The Clinical Documentation process begins with a clearly designed Evaluation Plan which, entails the methodological and systematic approach to reach adequate reporting. It provides a step by step approach in conducting and documenting each procedure. In the MDR, Chapter VI, Article 61 the critical issues to be considered for clinical data with regards to general safety and performance are discussed. Our experts have developed forms and templates that can be customized for mandatory procedures of the Clinical Evaluation Record.