Quality Management
A robust Quality Management System (QMS) is vital to the success of any medical device company. Whether it’s starting from scratch to obtain an ISO 13485 certification or improving an existing QMS, we create customized solutions to fit our client’s needs. We can provide training, 3rd party auditing and even on-site support for FDA, ISO and CE Mark inspections.
Regulatory Services
The road to success is full of speed bumps and in the world of medical devices, regulatory submissions are often the most difficult ones to navigate over. Whether it’s FDA 510(k) clearance, EU CE marking or a Health Canada medical device licence, we help our clients develop a clear regulatory strategy and compile a submission package that has the highest chance of success. We can also assist with preparation for other regulatory submissions such as IEC 60601 electrical safety testing and ISO 10993 biocompatibility assessment.
Technical Documentation
A well written Design History File (DHF) or Technical File is key to a successful regulatory submission. We can help develop requirements and specifications for hardware, electronics and software that meet the requirements of standards like IEC 62304 Medical Device Software and IEC 62366 Usability Engineering for Medical Devices. We also specialize in leading risk management processes compliant with ISO 14971 Application of Risk Management to Medical Devices as well as developing protocols for verification and validation activities.