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.

regulatory compliance and quality management

QUALITY AND REGULATORY SERVICES THAT MEET YOUR NEEDS

Quality Management

CAPA
Design Controls
Electronic Quality System
Quality and Manufacturing Plan
Be fully prepared for the FDA with our ISO 13485:2016 Certified quality management procedures. Quality management encompasses all of our design phases; our risk-based approach to medical device design gives you peace of mind that your device will be safe, effective, and of superior quality.

Risk Management

Hazard List
Design FMEA (DFMEA)
Application FMEA (AFMEA)
Manufacturing FMEA (MFMEA)
Begin medical device risk management early using our high-level hazard list. Next, we identify potential design failures and implement mitigative actions with our design FMEA. Finally, we repeat the FMEA focusing on the manufacturing process and the end-user. The result is a derisked medical device from start to finish.

Quality Documentation

Design History File (DHF)
Device Master Record (DMR)
Device History Record (DHR)
Product Design Specification (PDS)
Have all your documents ready for FDA review utilizing our proprietary electronic QMS. Synectic has the capability to generate new quality documentation for your medical device, as well as backfill in documentation needed for regulatory approval.

Regulatory Compliance

Sterility
Biocompatibility
Accelerated Aging
Verification and Validation
Stay FDA compliant with a variety of tests and studies available at your fingertips. Our engineers are well versed in all FDA regulatory controls for all classes of medical devices. We can perform any test, analysis, or study required to prove your device is safe and effective.