Our International Regulatory, Clinical & Quality Services

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 offering 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.

MCRA assists companies with all aspects of their International Regulatory, Clinical and Quality 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 insight and/or added bandwidth to meet internal and external timelines.

With the EU Medical Device Directive (MDD) 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 water.

International Regulatory Graphic

 

International Regulatory Graphic - World IconIntegrated US and OUS Market Roadmap

  • Design comprehensive strategic landscapes and timelines for the introduction of devices to US and global markets throughout the product lifecycle. 
  • Implement current and upcoming standards, regulations, and requirements, including the EU Medical Device Registration (MDR 2017/745), ISO 13485:2016, and MDSAP.
  • It is critical for manufacturers to think big picture as early in the process as possible when assessing your non-clinical and clinical evidence needs to collect the highest quality data cost-effectively with multiple reviewing bodies in mind (FDA, Notified Bodies, other global regulatory authorities, payors, internal marketing goals).

 

International Regulatory Graphic - Document IconTechnical 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, write, and review scientific, and technical documents, including Technical Documentation/STED through the use of MCRA's subject matter expertise. This includes the clinical evaluation described below.
  • Implement current and upcoming standards, regulations, and requirements into your Technical Documentation, including the EU Medical Device Registration (MDR 2017/745).
  • Provide response services to address Regulatory Authority (e.g., Notified Body) Questions.

 

International Regulatory Graphic - Clinical IconClinical Evaluation

  • Develop and update medical device CERs in compliance with MEDDEV 2.7/1 Rev. 4 and EU Medical Device Regulation (MDR 2017/745) (European 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.
  • Build a comprehensive evaluation of the State of the Art per MEDDEV 2.7/1 Rev. 4 literature search requirements.

 

International Regulatory Graphic - Graph IconPost-Market Surveillance/PMCF

  • The EU MDR requires a robust, integrated Post-Market surveillance program.
  • Strategize the process inputs and outputs across your PMS program, risk management, and CER.
  • MCRA can help strategize and implement PMS and PMCF needs including procedures and templates for plans and reports.
  • Navigate reporting requirements per MDR (e.g., device reportability, EUDAMED, SSCP, PSUR).

 

US and OUS Market Strategic Planning

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.