Quality Management System
Design Control, CAPA, NCMR, Complaints, Training
What we have found over the years is that overly complex systems hamper the basic mission of the company and may expose the company to compliance risk! That’s why we offer business Quality Management Systems that are designed to streamline your business and reduce the amount of time and money spent on quality management.
Vision28 QMSL is a complete 21 CFR 820 and ISO 13485:2016 compliant quality system. Paper-based, it is ideal for start-ups and growth-phase companies that don’t want to spend significant dollars for a medical device quality system and that want to get a system up and running in weeks instead of months. QMSL Standard Operating Procedures include:
- 0001-SOP Quality Manual
- 0002-SOP Design Control
- 0003-SOP Document Control
- 0004-SOP Purchasing Controls
- 0005-SOP Production and Process Control
- 0006-SOP Acceptance Activities
- 0007-SOP Nonconformance NCMR
- 0008-SOP Corrective and Preventive Action CAPA
- 0009-SOP Device Master Record
- 0010-SOP Device History Record R
- 0011-SOP Quality Records Rev A
- 0012-SOP Complaint Handling MDRs
- 0013-SOP Risk Management
- 0014-SOP Statistical Techniques
- 0015-SOP Personnel and Training
- 0016-SOP Internal Audits
- 0017-SOP Management Review
- 0018-SOP Handling Storage and Distribution
- 0020-SOP Installation
- 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.
- We have 20+ years experience with direct, hands on responsibility for the efficiency and effectiveness of quality systems
- Vision28’s Quality Management System has been reviewed in detail by FDA inspectors and by FDA Washing DC staff
- Notified bodies have certified Vision28’s Quality Management System as compliant to the EU Medical Device Directive
- Visio28’s Quality Management System as been updated to be compliant to the EU Medical Device Regulation
Contact us at your earliest convenience to learn about how our business Quality Management Systems can benefit you and your business. We have helped businesses of all sizes streamline their operations and save time and money in the long run. Let us show you what Vision28 can do for you.
Tom Renner is a seasoned engineering, quality and regulatory engineer whose experience 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 (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 management, 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.