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How to calculate the Analytical Evaluation Threshold for your Biocompatibility Assessment

22/07/2022

The Analytical Evaluation Threshold (AET) is the crucial parameter for demonstrating that your analytical results sufficiently assess the biological safety…

Fact Sheets

Using Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

31/01/2022

Last month (December 2021) the FDA published draft guidance regarding Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.…

Fact Sheets

Preparing your Premarket Submission for Device Software Functions

25/11/2021

The FDA has recently published draft guidance regarding the content of premarket submissions for device software functions. The guidance provides…

Fact Sheets

MDR adherence | MDCG guidance for Clinical Affairs

14/10/2021

Keeping track of the ongoing guidance for MDR adherence can be a time-consuming task. So to simplify your information-gathering process,…

Fact Sheets

8 tips for producing effective MDR Technical Documentation

02/09/2021

Producing effective Technical Documentation provides manufacturers with their own central information source regarding their medical device. Accurate Technical Documentation can…

Fact Sheets

How to determine legitimate FDA approval

10/06/2021

Within the medical devices field, you may have come across terms like “FDA registered”, “FDA certified” and “FDA Registration Certificate”.…

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A guide to 513(g) requests with the FDA

22/04/2021

A 513(g) request for information is a means for medical device manufacturers to obtain information about the FDA’s views regarding…

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3 steps to Classifying Medical Devices in the US

18/03/2021

The process of classifying a medical device in the US involves reviewing the potential regulatory class (I, II or III),…

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Fact Sheets

How to calculate the Analytical Evaluation Threshold for your Biocompatibility Assessment

Using Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

Preparing your Premarket Submission for Device Software Functions

MDR adherence | MDCG guidance for Clinical Affairs

8 tips for producing effective MDR Technical Documentation

How to determine legitimate FDA approval

A guide to 513(g) requests with the FDA

3 steps to Classifying Medical Devices in the US

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Fact Sheets

How to calculate the Analytical Evaluation Threshold for your Biocompatibility Assessment

Using Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

Preparing your Premarket Submission for Device Software Functions

MDR adherence | MDCG guidance for Clinical Affairs

8 tips for producing effective MDR Technical Documentation

How to determine legitimate FDA approval

A guide to 513(g) requests with the FDA

3 steps to Classifying Medical Devices in the US

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