Medical Device Consulting Services - Biotech Research Group

Posted by Kelly Shelton on November 18th, 2018

‘Biotech Research Group’ medical device consulting expertise is built upon our in-depth knowledge of the medical device manufacturing industry and our expertise in devising effective compliance strategies. By partnering with us, manufacturing enterprises are directed on how to implement effective solutions that drive business objectives and establish trust with clients.

Guiding Compliance Through All Stages of Manufacturing

From design to development to testing, Biotech Research Group directs quality, compliance, and regulatory efforts at each phase of the manufacturing process. Our experience allows us to assist with devising proactive strategies that include compliance awareness throughout a project, rather than as a bolted-on addition.

Biotech Research Group consulting expertise can provide practical and efficient guidance in the following areas:

• Regulatory and 510k submissions
• Comprehensive validation, covering devices, processes, and software
• Full remediation programs
• Unique Device Identification (UDI)
• EU Medical Device Regulation (MDR) Compliance
• In Vitro Diagnostic Regulation (IVDR) Compliance
• Meeting manufacturing compliance in foreign markets
• Risk management
• Handling new product regulatory applications
• Development and creation of Clinical Evaluations Reporting (CER)
• CE Marking
• Corrective Action/Preventive Action (CAPA) procedures, GxP validation, and the necessary documentation
• Restriction of Hazardous Substances (ROHS) concerns, such as tin-based solder issues
• Testing requirements
• Complaints and recalls

Medical device consulting to healthcare achievements around the world, and in order to ensure that safe and dependable instruments are being produced, Biotech Research Group delivers customized strategies that balance business goals with patient safety