Medical Device

We have successfully supported Class I De Novo & Class II 510(k) Substantially Equivalent Medical Device product launches.

ASQ CQA, CQE, & CPGP Certified Experts available

Business Strategy & Product Development

Qualified and experienced support for drug development and medical device manufacturing.

Quality Management System implementation and gap assessment.
Process validation for API batch synthesis, continuous commercial operation process performance qualification and validation of medical device drug substance combination products.
Program and process development utilizing principles of risk management, design qualification, FMEA, and process validation to ‘get it right the first Driving outcomes through continuous process improvement.
Experienced design input for new manufacturing facilities for drug substance manufacturing, medical device assembly, and laboratory support operations.
Scoping, planning, and project management of requirements for Computer System Validation in regulated environments including integration of multiple LIMS and QMS platforms.

Verification that Due Diligence has been applied.

Including pharma, medical device, and food GMP environments as described by Title 21 CFR § 111, 117, 211, 820 for manufacturing, storage, and laboratory operations.
Priority response and support for FDA citations, warning letters and Form 483. Management system Gap assessment and agency CAPA response.
Experienced CDMO management including supplier qualification, surveillance auditing, and for-cause auditing.
Management of custom starting material manufacturing, advanced intermediates, and APIs.
Equity Due Diligence. Assessment of management control systems and elucidation of potential risks, opportunities, and liabilities.