Michael G. Morello
Expert FDA Regulatory Compliance Consultant | QMS, Audits, 510k, PMA, Global Submissions | 15+ Yrs Exp.
Highly accomplished FDA Regulatory Compliance Consultant with over 15 years of progressive experience in developing and maintaining robust quality management systems, conducting comprehensive compliance assessments, audits, and gap analyses. Proven expertise in implementation plan development and regulatory intelligence across Pharmaceutical, In-Vitro Diagnostics, Medical Device, and Biotech industries. Adept at managing FDA GMP, DEA & ISO compliance, cybersecurity, and regulatory strategy for clients. Successfully navigated complex regulatory pathways, including 510(k)s, CE Marking, and PMA submissions, with a strong track record of positive client outcomes and successful product registrations globally. Dedicated to ensuring client adherence to stringent regulatory standards and driving continuous improvement.
HQ:
United States
Languages:
English
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Pricing model:
Custom pricing
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Traditional 510(k) Support, Abbreviated 510(k) Support, Special 510(k) Support
Pathways Supported:
Traditional 510(k), PMA
Device Types Supported:
IVD, Medical device, Combination product
Supports Estar:
No
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Supports Labeling Review:
No
Provides Submission Project Management:
No
Years Experience:
23
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
ivd, ophthalmic
Engagement Models:
hourly
Accepting New Clients:
Yes
