Our International Regulatory Services
MCRA can assist companies with all aspects of their International Regulatory needs from full service assistance to more refined scopes based on the needs of the company. MCRA aims to be an extension of your internal team to provide regulatory insight and/or added bandwith to meet internal and external timelines. Now that the EU Medical Device Directive (MDD) is being replaced by the EU Medical Device Regulation (MDR), the demands on medical device manufacturers are increasing, just as the number of Notified Bodies are decreasing. MCRA's multifaceted expertise in Clinical, Regulatory, Reimbursement, and Quality will ensure smooth sailing through uncharted MDR waters.
- Design comprehensive strategies and timelines for the introduction of devices to global markets throughout the product lifecycle.
- Execute successful registration through in-house expertise in the markets of Canada, Europe, Asia, Australia, Latin American, the Middle East, and Africa.
Technical Documentation Development and Maintenance
- Develop, write, and review scientific and technical documents, including Summary Technical Documentation (STED), design dossiers, and technical files, through use of MCRA's subject matter expertise.
Clinical Evaluation Report (CER) Development
- Develop medical device CERs in compliance with MEDDEV 2.7/1 Rev. 4, (European guideline) as well as, reports for other worldwide markets.
Regulatory Compliance Considerations
- Implement current and upcoming standards, regulations, and requirements, including the EU Medical Device Registration (MDR 2017/745).
Our Integrated Approach to International Regulatory
In an ever shifting and expanding global regulatory climate, the international markets are being driven more and more by an integrated regulatory, quality and clinical approach. MCRA's expert international regulatory, quality and clinical consultants provide the knowledge and experience to support medical device companies looking to gain access to established and emerging markets. In addition to the regulatory service offerings described, MCRA can assist with Notified Body identification, quality system and manufacturing compliance (e.g. ISO 13485 (2016), MDSAP preparation and implementation, internal audits, supplier/vendor audits, and clinical investigation services including pre-study activities and study execution.