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Product Development

What You Need to Know About Medical Device Software Validation

September 18, 2022
Software is certainly not a new concept to the medical device world. Read More
Product Development

MEDDEV 2.7/1 Rev. 4 & MDCG Guidance: Carrying Out Clinical Evaluation Under EU MDR

September 16, 2022
When regulatory bodies need to clarify or establish expectations regarding a part of their regulations, they put out guidance documents. Read More
Product Development

eCRF Template for Clinical Investigations and PMCF Studies

September 15, 2022
The key to an effective Electronic Data Capture (EDC) system setup is proper planning. If electronic Case Report Forms (eCRF) are not prepared well before setup, you can risk... Read More
Product Development

Building Your Regulatory Strategy for Commercialization

September 14, 2022
What should early-stage entrepreneurs and medtech companies consider with commercialization in relation to how regulatory strategy affects business roadmap, pitfalls... Read More
Product Development

Applying ISO 10993-1 to Medical Device Submission to FDA

September 12, 2022
ISO 10993-1 is the medical device industry’s globally recognized standard for biological evaluation of medical devices and protection of humans is its primary goal. Read More
Product Development

AAMI TIR45: Closing the Gap Between Agile Software Development & Medical Device Regulations

September 11, 2022
In 2012, the Association for the Advancement of Medical Instrumentation (AAMI) released the technical report AAMI TIR45 - Guidance on the use of AGILE practices in the... Read More
Product Development

MDCG 2020-6 Explained: Sufficient Clinical Evidence for Legacy Medical Devices in the EU

September 9, 2022
When EU MDR entered into force on May 26, 2017, it raised the bar for what constitutes sufficient clinical evidence to demonstrate a device’s conformity with EU regulations. Read More
Product Development

Packaging Validation Best Practices

September 7, 2022
The packaging of medical devices, especially sterilized products, is often overlooked and does not make news headlines until it’s done wrong. How can packaging and... Read More
Establishing a QMS

5 Steps for Getting your CE Marking with EU MDR Requirements

September 5, 2022
It has long been thought that the quickest path to market for medical device manufacturers is to access the European market by obtaining a CE marking instead of going through... Read More

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