Medical Device Consulting Services - Biotech Research Group
by Kelly Shelton Biotech Research Group is one of the leading data-‘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
consultants
- 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.
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Created on Dec 27th 2018 12:00. Viewed 382 times.