Regulatory Services For Medical Devices Industries
REGULATORY SERVICES FOR MEDICAL DEVICES INDUSTRIES
ISO 13485 and FDA compliance evaluations
Global regulatory strategies, FDA 513(g) requests and product classifications
Technical writing such as 510(k) submissions, explanation letters and clinical reviews
EU MDR 2017/745 and IVDR compliance through the following services
A comprehensive review of product portfolios and current certificate expiry dates
Gap assessment
Remediation and implementation of an EU MDR compliance plan
Post Approval support
Root cause investigation
Corrective and preventive action support
Complaint handling
Recall management
Consultation certification for manufacturers
USFDA 21 CFR part 820 Quality System Regulations
ISO 13485 Certifications
ISO 15378 Certifications
ISO 9001:2015 Certifications
Classification of medical devices
Identifying the appropriate pre-market submission pathway
Review of pre-clinical & clinical trial data
Compilation and Review of PMA, PMN, HDE applications in the specified formats by ensuring compliance with regulations pertaining to respective Health Authorities
Submission of application with relevant regulators to register the establishment & list the device
Post market regulations & processes : Monitoring & reporting patient incidents, involving the device, both to the manufacturer & to the FDA
