Executive summary of Omnica’s approach to design engineering services as it relates to medical device development, quality systems, design controls and design history.
Omnica’s expertise applies to Research & Development and Design Engineering with particular emphasis on the Life Sciences Industry and includes Mechanical Engineering, Electronics engineering, Software engineering, and Prototype Development of Medical Devices and Instruments. As such, Omnica is not a manufacture and does not have a formal written quality policy as defined in the Code of Federal Regulations (21CFR 820) and the ISO 13485 Standard for Quality Management Systems (QMS). Omnica provides development services for its client-manufacturers on a time-and-materials basis and functions as an extension of the client’s product development team, directed by them, as they manage their Product Development Process based on their Quality System. Results of the development effort at Omnica will support the way in which the client generates and manages their Design History File.
If you have had the opportunity to tour Omnica in person or virtually from this website, you will see that our facility is filled with equipment, tools, test labs, staging areas, etc. that support the collective creativity of our design team while providing the means for swift fabrication of engineering prototypes through the iterative process. As a result, while we design for manufacturing (DFM), we dedicate our resources to creative problem solving to swiftly deliver what others promise. It is therefore incumbent on the manufacturer’s development team to manage the Design Controls of their unique product relative to the categories described in the sections below. Omnica provides design output based on the design input requirements and we transfer the results of that effort to the manufacturer where they can integrate it into their Quality System for Design Controls while they build their Design History File.
All members of the Omnica team are creative design engineers and are aware of Quality Standards for the Life Science industry. Omnica uses good engineering, and good business practices for all programs having refined such practices over 35 years to ensure the highest quality output of those efforts. However, if Omnica is asked to support or perform a variety of “controlled” activities, those activities are directed by the client (with training if necessary) based on the requirements of their Quality System in support of their Design Controls. This ensures the consistency and continuity of their Design History File as the client-manufacturer (i.e., manufacturer of record) shall bear full and final responsibility for determining the suitability, safety, marketability, and overall fitness of the design(s) for any intended purpose.
The most successful development projects have always been dependent on the strength of good communication between the Omnica design team and the client’s project manager who manages the content of their Design Controls as they build their Design History File while working with their regulatory and quality teams. Therefore, the client’s project manager plays a vital role in eliminating the risk of derailing the creative design process and momentum of activity at Omnica.
History and introduction to medical device design & development with emphasis on design controls.
Approximately 85% of our clients hire us to design and develop medical devices and instruments. They range from small start-ups to large Fortune 500 corporations and all have two things in common: to see their ideas materialize and to overcome the challenges of incorporating the design and development process into their Quality System as defined by the law set forth in the FDA’s Code of Federal Regulations Title 21 Part 820 Quality System Regulation (i.e., 21 CFR 820 QSR). All medical device manufacturers must comply with this regulation by creating and working within their own Quality Systems. Most medical device manufacturers also attain what is known as “ISO 13485 certification” as a parallel enhancement to their Quality Systems. ISO 13485 refers to the international standard entitled: “Medical Devices – Quality Management Systems – Requirements for regulatory purposes”. Soon, it is likely the industry will see harmonization between 21 CFR 820 and ISO 13485.
Intrinsic quality, safety, and effectiveness of a device are known to be established during the design phase yet, statistics show that a significant percentage of all medical device recalls are due to design problems. As a result, in 1996, the Current Good Manufacturing Practice (cGMP) regulations enforced by the FDA were revised to include the area of Design Controls which became Part C of the law: Title 21 Code of Federal Regulations Part 820; and thus became known as Title 21 CFR Part 820.30. Therefore, each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a)(2) of the regulation shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. Furthermore, management with executive responsibility within that organization shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization. It is therefore incumbent on the manufacturer of record to demonstrate compliance with Good Manufacturing Practices, Quality System Regulations, and (as of 1996) Design Control requirements.
The Design Controls Ebook
The following is an introduction to the Design Controls section of the regulation (21 CFR 820.30). It will inform any medical device manufacturer that is working on a regulatory strategy for developing a new product. A list of references can be found at the end of the eBook that will point to additional information regarding development of a medical device, the Quality System Regulation, Design Controls and interfaces to be managed along the way. It is not a comprehensive list but highlights some of the ‘usual suspects’ to get you started.
So, grab your favorite beverage, sit back, and peruse this information at your own pace. Hopefully, you will benefit from its contents or it will reinforce what you already know.