Success in the rapidly changing and highly competitive world of medical devices demands people with the right experience and expertise. Test methodology, and regulatory strategy lead to costly delays.

GMPhar Consultants, We are dedicated to working with the medical device and related industries to help bring safe and effective products to the market in a timely and efficient manner. Our professionals have extensive regulatory and engineering experience.
We provides a broad range of regulatory consulting, engineering consulting, and regulatory department training services to meet your needs. Whether large or small, numerous companies have found our services invaluable to their medical device development and regulatory strategy processes.

Our services include:

• Quality assurance for medical device.
• Medical device manufacturing processes. Our team of consultants implemented GMP and ISO 13485 quality systems at medical device making a wide range of Class 1, 2 and 3 devices.
• Special advising in integrating ISO 14971:2007 risk management into existing ISO 13485 and GMP quality systems.

• Development of regulatory strategy for medical device development, pre-market submissions, and local authorities review.
• Provision of interpretation of applicable medical device, local regulations and guidance document requirements.
• Assistsance with:
  • Product labeling and Instructions.
  • Medical device import and export requirements.
  • Registration, listing, and reporting requirements.

Engineering Consulting Services

• Perform medical device design review.
• Assistance with:
  • Develop testing strategies and test methods.
  • Device failure analyses and the development and implementation of corrective action solutions.

Quality Assurance Consulting Services

• Analyze, design, and implement programs to meet GMP/ISO requirements.
• Assist with obtaining GMP/ISO certifications.
• Conduct pre- Local Regulatory Administration Authorities inspection audits and mock inspections.
• Provide QA/QRS training.