Medical Device regulatory consultation
HL ASSOCIATES
When you book a meeting or submit an inquiry, your contact details (name, phone, email) will be shared with the exhibitor so they can reach out to you directly.
HL ASSOCIATES
Local IT/consultancy service providersOverview
H L Associates is a regulatory consultancy firm which provides regulatory solution for medical device Since 2011. Our core service includes: 1. CDSCO MFG license i.e MD-05 (Class A & B), MD-09 (Class C & D) 2. Import license - MD-15 (Class A,B,C,D) 3.Loan license- MD-06 , MD-10 4. ISO 13485 certification & MDSAP 5. CE 6. USFDA 7. Health Canada, TGA , SFDA, SAPHRA, & Global registration 8. BIS, CRS, FMCS 9. BEP/BER service 10. Plant design & PMC 11. AMC Support for audit & compliance
Key Features
- 15+ Years of Regulatory Expertise, Specialized Medical Device Consultancy, End-to-End Regulatory Support, Global Market Access- US FDA 510(k), CE/EU MDR, UKCA, MDSAP and other country registrations, Technical Documentation & Risk Management, BEP & BER Support, QMS & ISO 13485 Expertise, Experienced Regulatory Team,