Quality System Implementation

All medical device-manufacturing companies in the US need to follow good manufacturing practices (GMP). Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation (QSR) of the 21 Code of Federal Regulations (CFR) Part 820. The FDA is responsible for monitoring the QSR compliance of all U.S. medical device companies.

Verotech’s Quality Team will provide valuable and informed insight for developing and implementing their client’s comprehensive quality plan.  We will also advise and assist in developing and maintaining quality management systems and continuous improvement initiatives.

 

Quality System Services Provided:

 
  • Quality System Implementation

    Our Team will provide valuable and informed insight for developing and implementing their client’s comprehensive quality plan.

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  • Medical Device

    Successfully validating a process may reduce the dependence upon intensive in process and finished product testing. Our Engineers have been involved in development of various new design concepts for our medical device clients

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  • Pharmaceutical

    Verotech Engineers have been involved in pharmaceutical manufacturing process validation activities with a product lifecycle concept and with existing FDA guidance, including the FDA/International Conference.

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  • Risk Assessment

    The US FDA, European authorities, Health Canada, the Australia Therapeutic Goods Administration and other regulators recognize it as the "de facto" standard for risk management.

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