Quality & Regulatory Support

At Synecco, building quality into all our processes means that we develop and produce solutions to satisfy both client’s quality requirements as well as international regulatory standards. Through our ‘continuous improvement’ approach, we are continually looking to improve our ISO13485 Medical Devices Quality Management System to meet and exceed our client’s quality expectations.

All our facilities, and the facilities to which we contract manufacturing in China, are fully certified to industry standards and are U.S. FDA registered to produce products and components for the medical device sector worldwide. Critical to Synecco’s offering is that we certify, approve and release all products manufactured on our behalf for our clients. Our rigorous Quality Management System ensures that we provide a consistent service that meets client and statutory requirements. We continue to strive to improve our quality systems and processes through internal review workshops following client audit and regulatory review findings. This process of continuous review and improvement means that we are constantly striving to perfect our quality controls to the highest standards, giving our clients total confidence in the quality of our clients products.

Quality

Our Quality & Facility Certifications Include:

U.S. FDA Registered

ISO 13485 (TÜV SÜD)

ISO 9001/2008 

Final verification and validation is undertaken to ensure product meets specification prior to the transfer to full scale production. Synecco offer our clients full process validation services through the provision of documented evidence to prove validation compliance with relevant regulatory requirements. At Synecco, our quality engineering tools include Process Failure Mode Effects Analysis (PFMEA), Control Plans and Process Validation. Process validation ensures that defined processes consistently perform according to specific parameters and include Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).

Key Capabilities Employed:

Tool Validation (IQ/OQ/PQ)
Process Validation
Product Verification
ISTA (Packaging) Testing
Age Testing
Sterilisation Test Report
Risk Analysis (PFMEA)
Equipment Sourcing
Qualifications
Testing

At Synecco we understand that the regulation of medical devices is a complex process and one that can change rapidly. By keeping well appraised of regulatory developments and requirements in all major markets and jurisdictions, Synecco can advise on and help support our client’s regulatory requirements from clinical approval to post market compliance.

Full range of clinical and regulatory support including

Quality Management
Validations & Qualifications Control
Regulatory Compliance
Preparation of Standard Operating Procedures
CE Marking
510K Submission
Specific Country Regulatory Advice

Featured Case Study

medical device quality management system