Hiren Patel
Montreal Dental
★★★★★
4.7
/ 5
•
191 reviews
Expert QA/RA Director | MedTech Product Launch | FDA, EU-MDR, MDSAP | QMS & Validation Specialist
Highly accomplished QA/RA professional with over 12 years of extensive experience in the medical device industry, specializing in design, quality assurance, and regulatory support from concept to commercialization. Proven track record of successful product launches, including COVID diagnostics, orthopedic implants, catheters, and SaMD. Expertise in navigating complex regulatory pathways such as FDA QSR, EU-MDR, and MDSAP, with demonstrated success in audit readiness and remediation for startups and established companies. Adept at developing and implementing robust Quality Management Systems, risk management, validation strategies, and managing cross-functional teams to ensure compliance and drive project success.
Buyer Snapshot
Best for
- MedTech companies seeking FDA, EU-MDR, or MDSAP compliance guidance
- Businesses needing support with Quality Management Systems (QMS) and validation
- Firms preparing for MedTech product launches
How engagement typically works
- Direct expert consultation
- Specialized regulatory and QA support
Typical deliverables
- Regulatory strategy and submissions
- QMS implementation and improvement
- Product launch support
Good to know
- Best when requiring US market regulatory expertise
HQ:
Tucker, United States
Languages:
English
Timezones:
EST
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, Traditional 510(k) Support, Special 510(k) Support, Abbreviated 510(k) Support, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k)
Device Types Supported:
IVD, SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
12
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
ivd, orthopedic, wearable_digital, other
Technology Types:
samd, wearable_patch, ivd_test
Accepting New Clients:
Yes
Supports Estar:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
