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Software as a Medical Device: Definitions, Examples & Regulatory Framework - Featured Image

Software as a Medical Device: Definitions, Examples & Regulatory Framework

Software as a Medical Device (SaMD) is a technology with limitless possibilities. In the hands of ta...
3 FAQ about CE Marking Medical Device Manufacturers Want to Know - Featured Image

3 FAQ about CE Marking Medical Device Manufacturers Want to Know

If you take a close look at many of the objects you use each day—keyboards, monitors, headphones, an...
What is ISO 9001 & Should Your Medical Device Company Follow It (or ISO 13485 instead)? - Featured Image

What is ISO 9001 & Should Your Medical Device Company Follow It (or ISO 13485 instead)?

Quality management is an essential part of manufacturing any product, regardless of size, complexity...
What is an ISO Audit? - Featured Image

What is an ISO Audit?

When it comes to medical devices, compliance isn’t based on the honor system.
Creating a Quality Manual That Complies with ISO 13485 - Featured Image

Creating a Quality Manual That Complies with ISO 13485

An excellent quality management system (QMS) is one of the keys to bringing a safe and effective med...
Goodbye EN 1041. Hello ISO 20417:2021. - Featured Image

Goodbye EN 1041. Hello ISO 20417:2021.

When you’re trying to bring a new medical device to market, it’s normal to be focused on actually bu...
How to Plan and Conduct an ISO 14155-Compliant Clinical Investigation - Featured Image

How to Plan and Conduct an ISO 14155-Compliant Clinical Investigation

Clinical investigations play an important role in your journey of bringing a medical device to marke...
4 Reasons to Get ISO 27001 Certification - Featured Image

4 Reasons to Get ISO 27001 Certification

The average data breach costs a company $3.86 million dollars. Perhaps worse than the financial burd...
Building a Startup in the MedTech Industry - Featured Image

Building a Startup in the MedTech Industry

What does it take to build a successful MedTech startup? It’s a multi-million dollar question and th...
How to Use Voluntary Consensus Standards to your Strategic Advantage - Featured Image

How to Use Voluntary Consensus Standards to your Strategic Advantage

If we were to say that it’s okay if you don’t follow all relevant standards when you develop your me...
5 Ways to Leverage Internal Quality Audits to Improve External Audit Outcomes - Featured Image

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

Your internal quality audits should be much more than a “checkbox” requirement on your compliance to...
Inside Look into ISO 14971:2019 & ISO TR 24971:2020 from the Author's Point of View - Featured Image

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

Keeping a constant pulse on current medical device industry standards for risk management, like ISO ...

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