Quality and Regulatory

AN ISO-CERTIFIED QUALITY MANAGEMENT SYSTEM TAILORED TO PRODUCT DEVELOPMENT

We provide medical device development from concept through pilot manufacturing under our quality management system (QMS), which is certified to ISO 13485 and 9001 standards, and compliant with FDA QSR 820 requirements. NOVO’s QMS was developed in house so that we could tailor it to the business of contract product development. Our certification allows us to develop under the design controls of our own QMS, or operate under our client’s QMS utilizing their procedures and forms. The system is applicable to non-regulated product development efforts as well, preserving best practices while adjusting documentation requirements appropriately.

For our established medical device clients who are already certified, choosing a development partner that is also certified eases the burden on supplier qualification. For startup clients that do not yet have their own certification, the project can be conducted under our certification while the client is developing their quality system.

Beyond our ISO certification, NOVO’s engineering team will comply with any published standard and is familiar with many of the standards that are relevant to drug delivery devices, primary containers, and other typical medical applications.

While NOVO does not offer production of finished medical devices, our QMS includes procedures and controls so that we can provide prototype manufacturing line development and controlled builds for clinical trial devices.

Each industry has a different set of regulations and standards with which they must comply. It is common for NOVO to have to comply with a previously unfamiliar standard. It is also common for us to interact with outside regulatory consultants to establish the appropriate standards for a particular type of device or instrument. See the list below for examples of standards we are familiar with.

Certifications and Standards

  • FDA QSR 820
  • ISO 13485/9001: 2003 certified
  • ISO 14971
  • ISO 11608
  • ISO 10993
  • ISO 23908
  • ISO 11073
  • ISO 11040
  • IEC 60601
  • IEC 60529
  • NEC/NFPA 70
  • UL, CE, CSA