Device registration requirements change significantly from country to country & time to time creating challenges for companies that operate in multiple markets.
For faster and risk free registration of dossiers, a comprehensive regulatory knowledge and proper interpretation of regulatory guidelines is most needed. Our global Medical Device Regulatory experts are well experienced in registrations and technical files management for regulatory authorities. Our team manages regulatory registrations of Medical devices and IVDs across USA, UK, EU and global markets.
510 (K)
As an FDA 510(k) regulatory specialist, we assist you in:
- Interpret FDA regulations and Ensure compliance with FDA standards and guidelines
- Assist in compiling the necessary documentation for 510(k) submission
- Identifying predicate device
- Evaluating the substantial equivalence
- Creation of 510(k) technical documents file
- Act as a liaison between clients and the FDA, responding to FDA queries and requests for information
- Our QMS specialized team helps manufacturers comply with 21 CFR part 820 QSR and ISO 13485 requirements
EU CE Marking
To make your approval process easier, MakroCare, an expert EU MDR regulatory company, helps manufacturers:
- Assisting with product classification
- Verifying applicable standards and testing requirements
- Compiling Technical Files or reviewing existing documentation
- Reviewing marketing materials, labels, and user manuals for compliance and consistency
- Ensuring adherence to Essential Requirements by developing GSPR
- Developing Clinical Evaluation Reports based on provided clinical data and literature search
- Implementing, adjusting, and maintaining a quality system (usually ISO 13485) to meet European and international criteria
- Providing European Authorized Representative services
- Conducting risk assessment and management following ISO 14971
- Developing vigilance and post-market surveillance procedures
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