End-to-End Medical Device Regulatory Services
Integrated medical device regulatory consulting, biocompatibility strategy, testing support, and pharma machinery consulting to help you navigate global approvals with confidence.
FDA Regulatory Support
We provide dedicated FDA medical device consulting and FDA submission support services, including FDA 510(k) consulting, remediation for existing products, and FDA deficiency response support. Our team guides you through biocompatibility strategy, toxicological justifications, and FDA ASCA program support so that your submissions are clear, risk-based, and aligned with current expectations.
EU MDR Regulatory Services
Our EU MDR consulting services cover MDR gap assessments, EU MDR technical documentation, and MDR biological evaluation support. We help you achieve EU MDR biocompatibility compliance with clear alignment to ISO 10993 requirements and provide MDR remediation for legacy devices already on the market.
Testing Strategy & Study Design Support
We design medical device testing strategies and biocompatibility study designs that are risk-based and efficient. This includes ISO 10993 test planning, predicate device justification, implantation study design consulting, and GLP laboratory coordination. Our team supports risk-based testing approaches for medical devices, including intramuscular implantation study planning and animal study strategy under ISO 10993.
Pharma Machinery & Engineering Support
For pharmaceutical manufacturers, we offer pharma machinery consulting services and pharmaceutical process equipment design. Our engineering support covers GMP compliant pharma machinery, solution preparation plant design, mixing tank design for the pharmaceutical industry, and CIP / SIP system design. We specialize in custom pharmaceutical equipment consulting, pharma engineering support services, and turnkey pharma machinery consulting for complex projects.