If you’re a medical device manufacturer – and especially a smaller one, such as a recent start-up – the real question might be “How can you NOT outsource quality assurance?”
Smaller firms such as start-ups are especially vulnerable to issues surrounding quality assurance and quality system development. Hiring an experienced QA professional or quality engineer can cut deeply into limited funds, never mind actually getting a Quality Management System (QMS) up and running. For small or newly-formed companies, dedicating an employee exclusively to quality and regulatory issues simply may not be feasible or cost-effective. However, careful adherence to regulatory compliance and affairs is crucial and cannot be treated as an afterthought. If design documentation is not developed right the first time, it will have to be reworked and redone during a submission, creating huge delays and extra costs
Outsourcing might be the solution. Even for larger companies with regulatory personnel, entering a new market or navigating unfamiliar regulations may be a challenge, requiring a new and different skillset for handling medical regulatory submissions and other critical tasks.
If outsourcing sounds like a good idea to you – and it should – it’s important that you work with the right medical device consulting firm for your specific situation and needs. For example, just because a consultant is experienced with FDA and GMPs does not mean they know European law especially the MDD. Just because a consultant is familiar with ISO 9001 issues does NOT mean they are also proficient in ISO 13485. Even a consultant with experience implementing ISO 13485 may not have the regulatory expertise to ensure that the applicable European requirements are embedded in the system.
But outsourcing is more than just hiring expertise. It’s about people. After all, if it’s difficult to work with outside medical device consulting professionals, all the experience and expertise in the world may not help you if that experience and expertise is met with resistance inside your organization. It’s important to work with an outside consultant with the personality and empathy to meld with your internal team and help build a positive team spirit with your staff. The last thing you need in the middle of a critical new project launch is your employees viewing the outsourced QA specialists as simply “hired guns.”
Quality assurance and regulatory compliance is serious business. Outsourcing for small-to-medium-size businesses often makes sense until they reach a point where the costs of outsourcing medical regulatory consulting expertise exceeds the cost of hiring an employee or two. Considering the evolving nature of regulatory affairs, outsourcing certain elements of your quality or regulatory responsibilities such as quality system development, auditing, 510(k) and other medical regulatory submissions, and technical file compilation may make sense, regardless of company size.