MEDICAL DEVICE COMPLIANCE
Complementing our engineering services, PASB offers trusted, competent medical device regulatory compliance consulting. Our personnel will work closely with you to find the most efficient regulatory pathway for your product or project.
As engineers we employ a structured problem-solving approach to medical device regulatory and quality projects which is supported by our practical experience in regulatory affairs, product development and manufacturing.
Medical Device Quality Assurance & Regulatory Affairs
Medical device manufacturers must navigate many complex region-specific regulatory systems to bring their products to market. We work with organizations ranging from start-up firms to global medical device manufacturers to ensure they meet applicable quality and regulatory requirements. We are formally trained in ISO 13485:2016 auditing through Exemplar Global and have practical experience in product design and manufacturing. Through our partners we have access to global expertise and resources in the medical device sector. The areas we support include:
Regulatory strategy development
FDA- and ISO 13485-compliant Quality Management System (QMS) development, implementation, and maintenance
FDA 21 CFR and Health Canada Medical Devices Regulations compliance support
EU MDR training and compliance
Design controls/design assurance: risk management to ISO 14971, DHF compilation, requirements traceability analysis
Implementation of IEC 62304 (Software Life Cycle Processes), IEC 62366 (Usability) and IEC 60601 requirements for QMS procedures and documentation deliverables
Process validation support (IQ/OQ/PQ) for manufacturing equipment
We are well versed in the new EU Medical Device Regulation (MDR) 2017/745 and can provide compliance support for device manufacturers transitioning to these new requirements.
Class II Device QMS
Develop and implement ISO 13485- and FDA-compliant Quality Management System
Software Life Cycle Processes
Develop IEC 62304:2006 Medical Device Software Life Cycle Processes framework for digital healthcare tech company
Pre-market FDA Liaison
Develop FDA pre-submission meeting strategy, meeting request package and assist in interactions with the FDA for start-up medical device company