FDA & ISO Quality Systems

ISO 13485:2016, 21 CFR 820 Off-the-shelf Quality Management System customized for your business, FDA & ISO audit tested. Minimal implementation time. ISO 13485:2016, 21 CFR 820, EU MDR, MDSAP.

ISO 13485:2016, 21 CFR Part 820, EU MDR, MDSAP

  • Globalization is driving European, US, Canada, Asia and other country Global Regulations and Quality Management Systems closer together.
  • MDSAP (Medical Device Single Audit Program) is now implemented across the globe.
  • EU Medical Device Regulation (MDR) is superseding the EU Medical Device Directive (MDD) effective May 2021.

Vision28 has implemented compliant quality systems from the ground up and we have modified client’s  existing systems for efficiency and compliance.  We have 20+ years working in industry while interfacing with FDA and Notified Bodies to demonstrate that our quality systems are efficient as well as compliant with global regulations.

  • Vision28 personnel are certified in EU MDR, ISO 13485:2016, 21 CFR 820 and MDSAP, with 20+ years of practical industry experience.
  • Vision28 professionals have experience developing and defending quality systems in companies ranging in size from worldwide Fortune 100 companies to start-ups trying to get their first products approved by the FDA and Notified Bodies.
  • Direct, hands on responsibility for the efficiency and effectiveness of quality systems. We don’t just consult, we roll up our sleeves and solve problems.
  • Vision28’s Quality Management System has been reviewed in detail by FDA inspectors, FDA Washington DC staff, and by multiple ISO 13485:2016 registrars.
  • Notified Bodies have certified Vision28’s Quality Management System as compliant with the EU Medical Device Directive and EU In Vitro Diagnostic Medical Devices Directive.

Contact us at your earliest convenience to learn about how our solutions can benefit you and your business.  We have helped businesses of all sizes streamline their operations and save time and money.  Let us show you what Vision28 can do for you.

CLICK HERE to contact us and to receive more information!

Tom Renner is a seasoned engineering, quality and regulatory engineer whose Tom Rennerexperience spans the United States, Japan, China, and Europe. Tom has a hands-on approach for all functions of a medical device start-up, from company genesis to international sales and public offering.

Tom has authored and implemented ground up quality systems for IVD and Medical Device manufacturers. His design control expertise will lead you through successful 510(k) clearance. His recent client list includes:

Medical Device Startup (United States):  Provided Preliminary Regulatory Assessment of new device with respect to Council Directive 93/42/EEC, EU MDR, MEDDEV 2.7.1 rev 4, and CE mark.

Growth Phase Medical Device Manufacturer (United States and Japan):  Provided 21 CFR 820 gap analysis and ongoing remediation of Japanese manufacturing facility of US combination product manufacturer.

Growth Phase Medical Device Manufacturer (United States and Japan):  Developed and managed ISO 13485:2016, ISO 14971:2019, 21 CFR 820, and MDSAP compliant quality system for a Class III medical device startup. Obtained successful ISO 13485:2016 and CE certificates. Created and maintained 10,000 page IMDRF-compliant Technical File during design and transfer to offshore manufacturing.

Growth Phase Medical Device Manufacturer (China):  Developed lean ISO 13485:2016 quality system for IVD startup.  Acted as QA/RA Manager during outsourced stateside design and development of their first product, with overseas manufacturing.

Growth Phase Medical Device Manufacture (United States):  Developed and managed emergency remediation plan for multi-site, vertically integrated, 350-employee medical device manufacturer with clean room automated assembly lines.  Led the combined 8-person employee/consultant team during 6-week rework of two discrete Japanese-language quality systems.  Successfully passed FDA inspection with no findings.

Medical Device Startup (United States): Developed ultra-lean, 14-procedure quality system for medical device startup.  Obtained successful ISO 13485:2012 certification.

Tom has the qualifications and experience to provide professional quality system management and support for your medical device company.

Rich Wynkoop is a seasoned executive who takes a pragmatic approach to quality 0049-b1389-rich-wynkoop-editmanagement, regulatory affairs, and compliance to achieve cost effective and successful outcomes. His experience spans world-class enterprises and multi-national organizations in medical device industries as a hands-on Quality Engineer, R&D Manager, QA Plant Manager, Director QA&RA, and Vice President QA&RA. This range of experience enables him to quickly target pragmatic solutions to difficult problems. Rich has also spent significant time preparing for and hosting regulatory audits and remediating difficult audit observations. He has designed and implemented Design Control, Software Validation, CAPA and other quality system elements that have stood up to robust examination by both Notified Bodies and FDA inspectors.