Quality and Regulatory Services
FDA focused and ISO certified quality management system
WE DE-RISK YOUR MEDICAL DEVICE DESIGN AT EVERY STAGE
Our FDA focused and ISO Certified quality management and regulatory compliance procedures encompass all our services, giving us an advantage over competitors. Unlike other product development companies, we begin the paperwork trail early, de-risking in the first stages of manufacturing. Here is what you can expect when you work with Synectic:
- A quality management system that meets or exceeds all FDA and ISO 13485:2016 documentation requirements, giving you peace of mind when seeking government and regulatory approval.
- Engineers experienced in designing all medical device classes, including highly regulated class III cardiac implants.
- Access to our new product introduction area, where we will de risk your assembly and manufacturing processes, mitigating potential risks before the FDA approval process.