Ask The Experts

 

MEDICAL DEVICE ACCREDITATION

Read the answers to some of the most frequently asked questions regarding the industry managed supply chain oversight program that reduces risk to patient safety, assures quality products and compliance with requirements as they apply to critical processes used in the production of medical devices.

Q: What is MedAccred®?
Q: How is MedAccred® different from the Medical Device Single Audit Program (MDSAP)?
Q: What is MedMMAP and how can it help me?
Q: How will my company benefit from achieving MedAccred® accreditation?
Q: What is a critical process?
Q: What is involved in a critical process compliance audit?

 

Quality Systems

To tackle the challenges and help guide the ISO 9001:2015 transition, the Michigan Manufacturing Technology Center has pooled the expertise of the Quality Services Team to offer insight and direction in navigating upcoming changes. 

Q: ISO 9001 was recently revised. What’s new?
Q: What documentation does ISO 9001 require?
Q: How do I document the "Context of the Organization"?
Q: What's "Risk Based Thinking" and what will the auditor expect to see?
Q: Will my internal audit program have to change to meet ISO 9001:2015?
Q: If the deadline for upgrading to ISO 9001:2015 isn't until Sept. 2018, what's the rush?
 

CYBERSECURITY

Cybersecurity is now firmly at the top of the national agenda as high-profile breaches raise fears that cyber attacks and other security failures could endanger the economy, businesses and individuals. The Center is on the pulse of cybersecurity and what it means for your business. 

Q: What is NIST Special Publication 800-171?
Q: What is Controlled Unclassified Information?
Q: Is there a compliance deadline for NIST Special Publication 800-171?
Q: What happens if my company doesn't implement cybersecurity initiatives?