Quality & Regulatory Consulting
Minimize risk and maximize speed with our compliance experts
Key Tech’s Quality Assurance and Regulatory team partners with startups to global corporations to ensure compliance with evolving health authority requirements. With over 25 years of experience developing medical, IVD, pharmaceutical, and life science devices, we offer comprehensive QA/RA consulting – either as standalone engagements or integrated into technical development programs.
Our experts help you identify the optimal regulatory path, navigate complex requirements, and ensure your product is fully compliant for market entry. Leveraging deep regulatory knowledge and in-house design capabilities, we provide practical, end-to-end support from planning to submission. Our QA/RA services include:
- Regulatory strategy for 510(k), PMA, De Novo, and CE Marking (MDR/IVDR)
- DHF gap assessments, remediation, and compliant design control documentation
- QMS reviews for compliance with 21 CFR Part 820 and ISO 13485
- Application of FDA guidance for software, usability, cybersecurity, EMC, and others
- Document preparation for FDA and notified body submissions
- Coordination of health authority and test lab interactions
Whether launching a new product or remediating an existing one, Key Tech ensures quality and regulatory compliance at every stage of the product lifecycle.
