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

 

Proven Quality Management System for Small Business and Startups

 

21 CFR 820, EU MDR, ISO 13485:2016 Compliant Off The Shelf Quality Management System
  • Vision28’s Quality Management System is a paper-based system that has been reviewed in detail by FDA inspectors, FDA Washington DC staff, and by multiple EU Notified Bodies, assuring your business is audit-ready with a proven quality system
  • We can have you up and running in two to four weeks
Strong Support Staff
  • Vision28 personnel has certifications 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 certified by Notified Bodies.
  • Direct, hands-on responsibility for quality systems. We don’t just consult; we roll up our sleeves and solve problems.
Pragmatic Approach
  • Lean procedures and forms
  • Paper-based system is economical and does not require you to learn new software or have your business interrupted by software bugs and crashes
  • Nothing beyond what FDA and EU require
  • Scalable as your company grows
Not a Template Approach
  • We customize the Quality Management System for your business
  • We can integrate your existing work instructions and procedures into the Quality Management System
  • We provide training and ongoing support
We are Focused on Startups and Small Businesses
  • We can be your virtual quality organization
  • We can create Design History Files, Device History Records, Device Master Records, perform validations, perform risk analysis… any function of a quality organization, all without you increasing headcount

 

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.