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Product Development

Creating a Supplier Scorecard for Medical Device Supplier Management

November 11, 2022
A supplier scorecard is one of the most effective tools medical device manufacturers have for assessing the performance of their suppliers. Read More
Product Development

The Future of Reprocessed Used Medical Equipment

November 10, 2022
What’s accelerated the growth of online healthcare device sales, and what’s the future of regulation regarding selling used medical devices? In today’s episode, we... Read More
Regulatory Submission

Understanding FDA Cleared vs Approved vs Granted for Medical Devices

November 10, 2022
As a medical device professional, you are well aware of how much time and effort goes into getting your product to market. So, with so much care put in every part of the... Read More
Product Development

The Difference Between Managing Product & Services Suppliers in MedTech

November 6, 2022
Both the FDA’s Quality System Regulations and ISO 13485 require medical device manufacturers to implement purchasing controls. The goal of those controls is to ensure that... Read More
Product Development

The Importance of Cervical Cancer Screening in the U.S.

November 4, 2022
The importance of cervical cancer screening in the U.S. Why is cervical screening so important in the U.S. and globally? And how has the pandemic affected that... Read More
Product Development

MDCG Guidance Documents Overview on Clinical Investigations and Evaluations

November 3, 2022
The EU Medical Device Coordination Group (MDCG) has provided a series of guidance documents for manufacturers to use on their path to MDR compliance. In April 2020, the... Read More
Product Development

Customer Discovery for Medical Device Companies

November 2, 2022
What is the customer’s ecosystem, and why do you need to know about it? In today’s episode, we spoke with Kari Haab about Customer Discovery for Medical Device... Read More
Regulatory Submission

7 Tips to Comply With FDA 21 CFR Part 11

October 28, 2022
When it comes to regulatory compliance for medical device companies, there can be some confusion around FDA 21 CFR Part 11.  Read More
Product Development

Why Investigator Initiated Studies Alone Are Not the Solution for PMCF Under EU MDR

October 27, 2022
The European Medical Device Regulation (EU MDR) requires medical device manufacturers to engage in post-market surveillance by establishing and implementing both a... Read More

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