OUR SERVICES
PASB offers trusted, competent engineering and regulatory support services for the medical device industry. 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:
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Regulatory strategy development
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Quality assurance consulting
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Supplier evaluation
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FDA- and ISO 13485-compliant Quality Management System (QMS) development, implementation, and maintenance
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FDA 21 CFR and Health Canada Medical Devices Regulations compliance support
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EU MDR training and compliance
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Design controls/design assurance: risk management to ISO 14971, Design History File compilation, requirements traceability analysis
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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:
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Concept development and detailed design using SolidWorks® 3D CAD Software
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Product design and development
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Engineering analysis including FEA (Finite Element Analysis)
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DFM - Design for Manufacturing
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Prototyping and fabrication sourcing
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Technical test protocol generation
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Independent product design reviews
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Development of instructions for use (IFU)
Medical Device Manufacturing Support
We can assist you with:
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Evaluation of manufacturing technologies at product design phase
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Process validation support (IQ/OQ/PQ) for manufacturing equipment
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Manufacturing process design, improvements, and implementation
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High volume manufacturing technology selection
Medical Device Regulatory and Quality Compliance Training
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Development and delivery of customized training specific to your company's products and markets
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Development of customized training modules that you can roll out to new and existing employees at your own schedule
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Audit preparedness training
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Software development and verification best practices per IEC 62304
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Risk assessment training and facilitation per ISO 14971:2019
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Training on EU MDR, FDA, and Health Canada regulations and approval pathways.
Medical device regulatory and quality system requirements are complicated. Understanding the requirements specific to your company's operations and device type(s) can by difficult.
We can help you and your team become comfortable navigating these systems by providing customized training that address the issues that are relevant to your company's products and business strategy.
Our offerings include:
