Amey Kawale
Expert QMS & ISO 14971 Risk Management Pro | EU MDR, SaMD, IVD Compliance | 10+ Yrs MedTech Experience
A highly accomplished Quality Management Systems (QMS) and ISO 14971 Risk Management professional with over 10 years of experience in the medical device industry. Specializing in EU MDR gap assessment, technical file remediation, and regulatory compliance for Class II/III medical devices, SaMD, and IVDs. Proven ability to lead global teams and harmonize complex QMS programs, with deep expertise in risk management processes including Risk Management Plans, DFMEA, UFMEA, PFMEA, Benefit-Risk assessment, Health Hazard Evaluations, and Risk Management Reports. Adept at driving design controls, technical documentation, and inspection-ready files in fast-paced, regulated environments. Successfully managed FDA QMSR projects, ensuring timely compliance.
HQ:
United States
Languages:
English
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) RTA Remediation / Refuse-to-Accept Fix, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Pre-Sub / Q-Sub
Device Types Supported:
IVD, SaMD, Medical device
Supports Rta Remediation:
Yes
Years Experience:
11
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
ivd, wearable_digital, other
Technology Types:
samd, ai_ml
Accepting New Clients:
No
