Quality and Regulatory Services
FDA focused and ISO certified quality management system
WE DERISK YOUR MEDICAL DEVICE DESIGN AT EVERY STAGE
Synectic’s advantage over its competitors is our FDA focused and ISO Certified quality management and regulatory compliance procedures encompassing all our services. Unlike other product development companies, we begin the paperwork trail early, derisking in the first stages of medical device design through to manufacturing. By incorporating quality and regulatory procedures early, we save you time and money by not having to fill in paperwork gaps in later costly phases.
We designed our quality management system to meet or exceed all FDA and ISO 13485:2016 documentation requirements giving you peace of mind when seeking government and regulatory approval. Whether your path to market is a shortened 510(k) or the full premarket approval (PMA) process we have the capabilities necessary to guide you through the process. Our engineers have experience designing all classes of medical devices, including highly regulated class III cardiac implants. With our new product introduction area available to derisk your assembly and manufacturing processes, you can mitigate any potential risks before the FDA approval process.