Quality and Regulatory

QUALITY MANAGEMENT SYSTEM CERTIFIED TO ISO 13485:2016

Medical device development in the United States is regulated under FDA 21 CFR Part 820, also referred to as Quality System Requirements, or FDA QSR. It is the stated intention of the FDA to harmonize their requirements with ISO 13485:2016, an internationally accepted standard. When the harmonization becomes official, it will be a welcome simplification for companies in the medical device industry.

The general standards ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes, and ISO 14971 Medical devices — Application of risk management to medical devices, are the umbrella standards for medical device hardware and software development. The FDA recognizes that compliance with the Consensus Standard IEC 62304 satisfies regulatory requirements for medical device software development (software as a medical device, or SaMD). NOVO complies with all relevant FDA, ISO, and IEC regulations and standards.

NOVO provides medical device development services from concept through R&D assembly line development and manufacturing transfer under our quality management system (QMS), which was first certified to the ISO 13485 standard in 2015. Our QMS was constructed to be compliant with FDA QSR 820 requirements from the outset. We chose to develop a proprietary QMS so that we could incorporate our product development and project management processes into the procedures. The result is a coherent set of procedures that include best practices that promote product development efficiency and predictability. The system is so effective that we use it for non-regulated product development as well, preserving best practices while adjusting documentation requirements appropriately.

Some of our clients are startups who do not have their own quality systems. These clients typically leverage NOVO’s QMS early on so that they can begin generating compliant documentation from the beginning of their development effort. Our established medical device clients prefer that NOVO’s developers work within their quality systems, using their procedures and forms. We are happy to work within our client’s systems and our own QMS contains procedures for allowing this. Whether the client is already ISO-certified, or still implementing their own quality system, working with an ISO-certified engineering services provider, familiar with the regulatory environment, will accelerate regulatory approval.

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, in addition to standards published by standards organizations and regulatory bodies other than ISO or the FDA. We have provided as list of familiar standards below for reference. We commonly work with outside regulatory consultants to establish regulatory strategy and plans.

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 design verification or pre-clinical applications.