PASB MedTech Solutions

PASB MedTech Solutions provides comprehensive consulting assistance to medical device firms, with a focus on complex regulatory and quality management requirements in major global markets.
Our mission is to build lasting relationships by continually providing robust, comprehensive, and value-added solutions that improve human health, quality of life, and contribute to a better future for all.
We support clients in English and German, from early-stage companies to established organizations, working closely with them in pre-market and post-market phases to streamline market access and ongoing compliance in North America and Europe. During this process, we continually strive to align regulatory and quality strategies with overarching product development and commercialization goals. Our services cover the entire medical device lifecycle and include:

Regulatory Affairs
• Regulatory assessments and strategy (Canada / USA / EU)
• Regulatory submissions (Health Canada, US FDA, EU CE marking)
• EU MDR/IVDR transition management
• Labelling and advertising compliance
• Regulatory affairs fractional support

Quality Management Systems
• ISO 13485 and FDA QSR-compliant QMS development, implementation, and training
• MDSAP gap analysis and remediation
• Design controls and DHF compilation
• Risk management according to ISO 14971
• Verification and validation test planning
• Software & cybersecurity QMS considerations
• Quality management fractional support

Investor Readiness / Commercial Support
• Business case analysis and business planning
• Import/export strategy
• Preliminary reimbursement assessment (USA)