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Find the latest content and resources from our team of experts to keep you in the know for all things quality and regulatory in the life science industry.
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Companies are often in doubt about outsourcing Internal Audits especially when they have an in-house quality ...
If you are developing a medical device, you will need to become familiar with Design Controls. 21 CFR 820.30 ...
Complaint handling can be a daunting task especially if you are a small company. 21CFR 820 requires customer ...
Do you have a medical device that treats or diagnoses a life-threatening disease? If yes, your device may be ...
As a medical device manufacturer, every company must establish a QMS in compliance with 21CFR 820 (if you sell in ...
The process of creating, manufacturing, and marketing a medical device can be extremely difficult to navigate. ...
Making a change to the design or the manufacturing process of your product that is already out in the field? You ...
Clinical Decision Support Software is a tool that is utilized in making decisions for the diagnosis, treatment, ...
Having a regulatory strategy to bring your device to the market may not seem like the most exciting part of ...
A 510(k) is the most utilized regulatory pathway to market a medical device in the US. For a device of the same ...
If you’re considering selling your medical device in Europe, you will need a Notified Body, and you’ll need to ...
The terms “Form 483” and “warning letter” can incite dread for those that market their medical device in the US, ...
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