Our Global Regulatory Approach
In an ever shifting and expanding global regulatory climate, MedTech markets are being driven by a more integrated regulatory, clinical, reimbursement, and quality approach. MCRA's expert regulatory consultants provide the knowledge and experience to support medical device and in vitro diagnostic device companies looking to gain access to established and emerging markets.
MCRA believes in taking a global approach to global regulatory consulting for medical devices, and takes time to understand clients' long-term goals. This allows us to develop the most efficient and cost-savings pathway for your medical device to global entry. There is overlap in global MedTech markets that creates opportunities to leverage documentation and evidence, and support regulatory work in multiple markets. This allows us to assist clients in reducing costs and expediting time to market for your medical device. MCRA's global regulatory consulting experts have expertise in a number of geographies to help manufacturers identify potential markets and obtain market clearance for their medical device.
Our Global Regulatory Services
MCRA is the first medical device regulatory consulting company to integrate expert services within a team of regulatory subject matter experts, creating the partner of choice in clinical, regulatory, reimbursement, quality assurance, compliance, and expert services such as biocompatibility, statistics, usability, cybersecurity. MCRA’s Regulatory Team has an unprecedented success rate for PMA’s, 510(k)s, breakthrough designations, and CE mark applications with extensive therapeutic expertise in a wide range of clinical focus areas. MCRA’s team includes former FDA assistant directors, branch chiefs, team leads and reviewers, former senior Notified Body reviewers, and 50+ veteran medical device experts with over 15 years’ experience.
Global Market Strategic Planning
MCRA delivers integrated, region-specific regulatory strategies that help you enter global markets faster and stay compliant throughout your product’s lifecycle. From the US, EU, and UK to Canada, Japan, Australia, and beyond, we navigate complex regulations for medical devices and in vitro diagnostics—ensuring smooth approvals, efficient market access, and sustained compliance.
In addition, MCRA offers critical assessments of market access preparedness and data generation strategies early in the process to establish non-clinical and clinical evidence needs—helping manufacturers generate the highest quality data cost-effectively, with multiple reviewing bodies in mind.
MCRA provides regulatory strategic services at any stage of the process. We offer ad-hoc communications and meetings with subject matter experts, represent clients in interactions with regulatory bodies, and deliver custom training for your team on medical device regulatory expectations, requirements, and processes.
Global Regulatory Roadmap for Medical Device Market Entry
Medical device and IVD manufacturers face a web of diverse regulatory frameworks worldwide. In the US, the FDA enforces the FD&C Act and 21 CFR Parts 800–899, while Japan requires compliance with the Pharmaceuticals and Medical Devices Act. Canada’s MDR (SOR/98-282) governs product safety and performance in that market.
In Europe, the EU MDR (Regulation (EU) 2017/745) and EU IVDR (Regulation (EU) 2017/746) set rigorous requirements for CE marking, while in the UK, the UK MDR and UK IVDR—based on Regulation 2002 and subsequent amendments—define the pathway to market access.
With expertise spanning these major markets and beyond, MCRA provides the insight, strategy, and execution to guide your product from concept to commercialization—globally.