Medical device companies must overcome many hurdles to get safe, high-quality products to market. While their primary objective—creating safe, innovative, and valuable health solutions—is challenging enough, medical device companies must also navigate a myriad of regulatory compliance issues before products can be sold to doctors, hospitals, and patients. Accelerating the delivery of new products while ensuring compliance requires comprehensive design controls leveraging the best technologies and automated systems to keep quality and product teams aligned to collaborate quickly and effectively.
To ensure patient safety, the Food and Drug Administration (FDA) and International Organization for Standardization (ISO) stipulate that medical device manufacturers establish and utilize a quality system to ensure products consistently meet regulatory requirements and applicable ISO 9001 and 13485 standards. This type of system, or collection of policies, procedures, and processes, is known as a quality management system (QMS) and helps medical device companies establish and document policies and procedures to demonstrate compliance.
“Implementation was made very easy by Arena giving us complete IQ and OQ documents. The wide range of standard out-of-the-box functionality narrowed the scope of our work even more. This resulted in a very productive and complete PQ while requiring much less management than other IT system implementations I have been a part of.”
– Ed Reith, Supply Chain Engineering Manager, EBB
Medical device companies can leverage manual, paper-based, homegrown software, or purchased software QMS solutions. The FDA does not regulate what type of QMS solution is used. Regardless of the type of QMS solution used, companies must demonstrate and provide evidence, or validate that it meets the requirements to consistently deliver safe, high-quality devices to market.
One very important consideration when selecting any QMS solution involves the level of effort and ultimate cost to validate. QMS validation is considered an overhead cost required to satisfy the FDA and get products to market; it is not part of the material and assembly cost, since it is not directly related to producing the physical product.