The regulatory landscape is constantly changing. Our experts ensure you stay on top of it all
- 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
