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Product Development

What are the Risk Management Documentation Requirements of ISO 14971?

August 7, 2022
Managing risk is one of the most important areas in medical device manufacturing today. Not only does it protect users and patients, it’s also a major requirement of most... Read More
Product Development

3 ISO Compliance Guidelines Every Medical Device Manufacturer Should Follow

August 5, 2022
The word “compliance” can sound like a chore,  or some sort of box to check before punching out at 5:00. However, in the medical device industry, compliance is more than a... Read More
Product Development

Digitizing your SaMD Testing

August 3, 2022
What is software as a medical device (SaMD)? How does one test SaMD? What testing is required? What are the risks related to your SaMD and its testing?  Read More
Product Development

Why is Post-Market Surveillance Important for Medical Devices?

August 2, 2022
The European Medical Device Regulation (EU MDR) is drastically changing the regulatory framework for medical devices. One of the new major challenges is the increased focus... Read More
Product Development

Why Training Compliance Matters for Pre-Market MedTech Startups

July 31, 2022
Medical device companies in the pre-market stage tend to put training compliance on the backburner. It’s not that there aren’t directions for achieving compliance—ISO 13485... Read More
Product Development

3 Common Problems with Design Controls (and the Solutions)

July 29, 2022
The first time you looked at 21 CFR Part 820.30—FDA’s regulations for design control—you probably thought, “Is that it?” Read More
Product Development

Examining FDA’s Refusal to Accept (RTA) Policy and Guidance

July 27, 2022
After three “Refusals To Accept” Guidance Documents from the FDA, why are there still so many submission issues? Who’s to blame? Learn from other people’s mistakes.  Read More
Product Development

Integrating Connected Device Data into Your Clinical Study

July 26, 2022
Connected devices are devices that may or may not be approved/cleared medical devices. They can be used in multiple places, e.g., a device that is under investigation itself,... Read More
Product Development

Downstream Effects of Inadequate Complaint Handling

July 24, 2022
Getting a product to market is the number one goal of any MedTech startup. But the job isn’t over once that product is on the market—it’s just the beginning. Read More

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