MDSAP, ISO 13485:2016, 21 CFR 820, Medical Device Regulation Audits
COVID-19: How to Audit
- During the COVID-19 restrictions on travel, Vision28 can perform virtual audits to fulfill your QMS audit obligations
- We will use Drop Box, Image Transfers, Face Time and Web based meeting applications
Why perform Quality Audits?
- Quality Audits are required by regulation
- They identify systemic gaps in regulatory compliance
- Causes of poor product quality may be identified
- Audits may be leveraged to identify process improvement and cost reduction opportunities
Our Medical Device Auditing Services include:
- Gap analysis audit
- MDSAP, MDR or FDA Pre-assessment audit
- FDA inspection – Assist during an actual FDA inspection by managing the “back room,” taking minutes, or interfacing with FDA
- Mock audits to train employees
- Full or partial internal audit
- Subcontractor or supplier audit
- Our auditor certifications include ASQ Certified Quality Auditor (CQA), Certified EU MDR 2017/645 Auditor, and ISO 13485:2016 Auditor
- We will tailor the audit to your needs, whether it is an entire system audit or if you have a specific area of concern we can do a more thorough review and provide guidance in that area
- We focus on what is important in terms of compliance
- Auditing experience ranges from 10 to 20+ years
- We do more than audit, we also suggest potential process improvements that may save you money by eliminating unnecessary or redundant process actions
Call us at (541) 604-9654 or email us at firstname.lastname@example.org to learn about our medical device auditing services and how they can benefit your business. Rich and Angela will be happy to explain our auditing services and how we can help.
Angela Kiser is a Certified Quality Auditor (CQA) from the American Society for Quality (ASQ), is a Certified EU MDR 2017/645 Auditor through Oriel Stat-a-Matrix, and an ISO 13485:2016 Lead Auditor through British Standards Institution (BSI) and has over 10 years of audit experience. Angela will be certified to MDSAP at the end of April. Angela has worked in all aspects of Quality Assurance, including Design Control, CAPAs, and Complaints. She has created and revised complete quality systems to comply with the latest FDA, ISO, MDD and the new EU MDR regulations.
Angela is also experienced with the unique requirements of software as a medical device and can guide organizations on how to best implement and maintain a quality system around software development.
Angela has also worked as a Clinical Trial Project Manager, coordinating all activities required for setting up and monitoring clinical studies and provided oversight to clinical investigators, study sites, and other trial team members.
Angela has the qualifications and experience to provide professional audit services, quality system management, or clinical study project management for your medical device company.
Rich Wynkoop is a Certified EU MDR 2017/645 Auditor through Oriel Stat-a-Matrix, and an ISO 13485:2016 Lead Auditor through SAE International and has over 20 years of audit experience. Rich will be certified to MDSAP at the end of April. Rich has managed both large and small quality organizations as Quality Plant Manager, Director, and Vice President for major medical device companies. He has created and revised complete quality systems to comply with the latest FDA, ISO, MDD and MDR regulations.
Rich has the qualifications and experience to provide professional audit services, quality system management, and strategic quality and regulatory planning for your medical device company.