REGULATORY SERVICES FOR MEDICAL DEVICES INDUSTRIES

MEDICAL DEVICE PRODUCT DEVELOPMENT & QUALITY MANAGEMENT

• Medical device companies, more specifically product development and quality teams, are expected to deliver innovative, life-changing medical device(s) at a rapid pace, all while maintaining compliance and achieving true quality – no pressure
• This balancing act of staying up-to-date with the ever-changing regulations and satisfying the need to work efficiently, while scaling processes, has made product developers’ and quality professionals’ heads hurt
• To help paint a picture of the strategies, tactics, and technologies today’s medical device professionals are using to accelerate product development, ensure compliance, and promote quality

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FWQRC provides FDA compliance solutions to medical device manufacturers

• 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