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MEDICAL DEVICES

PASB offers trusted, competent engineering and regulatory support services for medical devices. As engineers we employ a structured problem-solving approach which is supported by our practical experience in regulatory affairs, product development, manufacturing and automation. We have experience navigating the medical device product lifecycle from concept to finished product. We collaborate with you wherever you are in the medical device development process. We provide services in the following areas: 

 

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 certified ISO 13485:2016 auditors 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, Design History File 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

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.

 

Medical Device Product Development

There is a push to automation and high volume manufacturing in the medical device industry. PASB offers the following medical device product development services:

  • Concept development and detailed design using SolidWorks® 3D CAD Software

  • Product design and development

  • Engineering analysis including FEA (Finite Element  Analysis)

  • DFM - Design for Manufacturing 

  • ​Prototyping and fabrication sourcing 

  • Quality assurance consulting

  • Supplier evaluation 

Medical Device Manufacturing Support

We can assist you with:

  • Evaluation of manufacturing  technologies at product design phase

  • Process validation support (IQ/OQ/PQ) for manufacturing equipment

  • ​Manufacturing process design, improvements, and implementation

  • High volume manufacturing technology selection 

  • Supplier evaluation​

 

RECENT PROJECTS

  • Medical Device DFM

    Design for manufacture (DFM) for high volume production of next generation glucose monitoring devices

  • Class II Device Software Life Cycle 

    Develop IEC 62304:2006 Medical Device Software Life Cycle Processes for healthcare tech company

  • Class II Device QMS 

    Develop and implement ISO 13485- and FDA-compliant Quality Management System

  • 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 

PASB Technical Solutions Inc.

6 Berrigan Place, St. John's, NL A1B 1Z9, Canada

Tel: +1 709 699-6113

Email: info@pasb.ca

Copyright © 2020 PASB Technical Solutions Inc. - All Rights Reserved.