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MedTech Lifecycle Excellence

Ad Promo and The Difference in Regulatory & Legal

May 24, 2023
What are the 4 buckets of information that MedTech professionals should consider when commercializing their device? Where is the line between perspectives when it comes to... Read More
Product Development

How To Use FDA’s Guidance on Post-Approval Studies During Premarket Approval

May 24, 2023
In the US, post-market clinical studies are not required of every medical device manufacturer. However, FDA does have the authority to order post-market surveillance of any... Read More
MedTech Lifecycle Excellence

How AI Can Help You Manage Risk

May 17, 2023
With the advent of new Artificial Intelligence (AI) tools, where is risk management headed? How are they affected by the changes? Risk management is essential and becoming... Read More
Product Development

The Risk Management + Design Controls Connection: What Device Makers Need to Know

May 16, 2023
Medical devices are intended to save and improve quality of life. Read More
Product Development

How To Vet Medical Device Distributors in Multiple Markets

May 15, 2023
The majority of medical device companies, even the relatively big ones, will need third-party distributors to get their devices to market. Read More
Product Development

What is the Best Way to Structure a Risk Management File?

May 14, 2023
The medical device risk management process relies heavily on the use of documentation. Whether the activity is conducted onsite or offsite, during design or after... Read More
Clinical Data Collection

The Tools that Make Clinical Investigations

May 12, 2023
What makes a clinical investigation run smoothly? In today’s conversation, you’ll hear from Jon Bergsteinsson as we speak about electronic data capture for clinical... Read More
Regulatory Submission

7 Tips for FDA 21 CFR Part 11 Compliance

May 12, 2023
When it comes to regulatory requirements for medical device companies, there can be some confusion around FDA 21 CFR Part 11 compliance. Read More
Product Development

eIFU Requirements: Everything You Need to Know About Electronic Instructions for Use

May 11, 2023
It doesn’t matter how well-engineered or high-quality your medical device is; you still need to make sure people know how to use it. Read More

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