Our Global Regulatory, Clinical & Quality Services
In an ever shifting and expanding global regulatory climate, markets are being driven more and more by an integrated regulatory, quality, and clinical approach. MCRA's expert regulatory, quality, and clinical consultants provide the knowledge and experience to support medical device companies looking to gain access to established and emerging markets world-wide. In addition to the regulatory service offering described, MCRA can assist with Notified Body identification, quality system and manufacturing compliance (e.g. ISO 13485), MDSAP preparation and implementation, internal audits, supplier/vendor audits, and clinical investigation services including pre-study activities and study execution.
MCRA assists companies with all aspects of their Global Regulatory, Clinical and Quality needs, from full-service assistance to more refined scopes, based on the needs of the company. MCRA partners with your internal team to provide insight and/or added bandwidth to meet internal and external timelines.
With the transition to new European regulations, 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 help you navigate and increasingly complex and evolving regulatory landscape.
Integrated Global Market Entry Roadmap
- Design comprehensive strategic plans and timelines for the introduction of devices to global markets throughout the product lifecycle.
- Implement current and upcoming standards, regulations, and requirements, including FDA and EU Medical Device (MDR 2017/745) legislation, ISO 13485:2016, and MDSAP.
- Critically assess and prepare market access and data generation strategies early in the process to establish non-clinical and clinical evidence needs, generating the highest quality data cost-effectively with multiple reviewing bodies in mind (FDA, Notified Bodies, other global regulatory authorities, payors, internal marketing goals).
Technical Documentation and Product Registration
- Execute successful registration through in-house expertise in the markets of Canada, Europe, Asia, Australia, Latin America, the Middle East, and Africa.
- Develop, create, and review scientific, clinical and technical documents, including Technical Documentation/STED through the use of MCRA's subject matter expertise. .
- Implement current and upcoming standards, regulations, and requirements into your Technical Documentation, including state of the art gap assessments and remediation strategies.
- Provide response services to address Regulatory Authority (e.g., Notified Body) Questions.
- Develop and update medical device CERs in compliance with MEDDEV 2.7/1 Rev. 4 and EU Medical Device Regulation (MDR 2017/745) (including MDCG guidelines) as well as reports for other worldwide markets.
- Assist with assessing large product portfolios for strategic placement of devices within the Technical Documentation and CERs.
- Evaluate your clinical evidence for data sufficiency to demonstrate conformity with the relevant Essential Requirements/General Safety and Performance Requirements or other key regulatory benchmarks.
- Build a comprehensive evaluation of the State of the Art per MEDDEV 2.7/1 Rev. 4 literature search requirements.
- Develop robust, integrated Post-Market surveillance programs, interfacing with clinical data, risk management and state of the art market feedback.
- Strategize the process inputs and outputs across your PMS program, risk management, and CER ensuring continuous review and alignment of benefit risk and compliance.
- MCRA can help implement PMS and PMCF requirements including procedures and templates for plans and reports.
- Navigate reporting requirements per MDR (e.g., device reportability, EUDAMED, SSCP, PSUR).