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Establishing a QMS

Four Years, For You

September 27, 2022
Celebrating Four Years as the Leading QMS, as Selected by Users Read More
Product Development

Ultimate Guide to Supplier Management for Medical Device Companies

September 25, 2022
A medical device is only as good as its parts. Read More
Product Development

IEC 82304 vs IEC 62304: Software Standards for SaMD Explained

September 23, 2022
IEC 82304-1 is one of many standards that medical device companies should use while developing software as a medical device (SaMD). It covers the requirements for... Read More
Product Development

Compliant Adverse Event Reporting in Clinical Studies under the EU MDR

September 22, 2022
Under the EU MDR, both pre- and post-market clinical investigations shall follow the latest requirements for Good Clinical Practice (ISO 14155:2020). Recording and reporting... Read More
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

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

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