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.
QUALITY AND REGULATORY SERVICES THAT MEET YOUR NEEDS
Quality Management
CAPA
Design Controls
Electronic Quality System
Quality and Manufacturing Plan
Design Controls
Electronic Quality System
Quality and Manufacturing Plan
Be prepared for the FDA with our ISO 13485:2016 Certified quality management procedures encompassing 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)
Design FMEA (DFMEA)
Application FMEA (AFMEA)
Manufacturing FMEA (MFMEA)
We begin risk management early with 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 product from start to finish.
Quality Documentation
Design History File (DHF)
Device Master Record (DMR)
Device History Record (DHR)
Product Design Specification (PDS)
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
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.
