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FDA Regulations

How to Use Voluntary Consensus Standards to your Strategic Advantage

February 28, 2021
If we were to say that it’s okay if you don’t follow all relevant standards when you develop your medical device, you’d probably think we were a bit crazy, right? Read More
FDA Regulations

Preparing for Remote and On-Site Inspections and Audits

February 24, 2021
How can medical device companies be better prepared for remote and on-site inspections and audits? Practice, practice, practice so that you’re always audit-ready. Read More
Global Medical Device Podcast

How does EU MDR impact your Quality Management System?

February 22, 2021
The new medical device regulation in the European Union (EU MDR) has introduced a host of new challenges for medical device companies. One challenge, in particular, has to do... Read More
Global Medical Device Podcast

Virtual Auditing in a Post-COVID World of Digital Compliance

February 17, 2021
What do auditing and compliance protocols look like during a pandemic? Medical device companies continue to adjust to changing circumstances in an attempt to maintain... Read More
FDA Regulations

5 Ways to Leverage Internal Quality Audits to Improve External Audit Outcomes

February 14, 2021
Your internal quality audits should be much more than a “checkbox” requirement on your compliance to-do list. Internal audits must be regularly scheduled according to a... Read More
Global Medical Device Podcast

Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View

February 10, 2021
Keeping a constant pulse on current medical device industry standards for risk management, like ISO 14971:2019 and its companion documents, while also adhering to the... Read More
Product Development

Prioritizing Medical Device Reimbursement During Product Development

February 3, 2021
Medical device reimbursement is a key consideration that must be well researched, understood, and managed by companies in order to ensure no money, to which you’re entitled... Read More
Regulatory Affairs

Definitive Guide to Change Management for Medical Devices

January 22, 2021
In an industry that is ever-evolving, change is inevitable. Read More
Global Medical Device Podcast

What are the Strategic Priorities for CDRH in 2021?

January 20, 2021
What are the 2021 strategic priorities for FDA’s Center for Devices and Radiological Health (CDRH) and what impact will these initiatives have on the medical device industry? Read More

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