Entries by Meghan

Data Integrity: A hot topic in FDA Warning Letters

Data integrity continues to be a focus during US FDA inspections. A number of warning letters issued by the FDA in 2022 highlight the importance of Data Integrity compliance.
In the warning letters issued, the FDA references the FDA’s guidance …


Clinical Evaluation EU-MDR requirements

Clinical Evaluation EU-MDR requirements 
This article provides a brief overview of Clinical Evaluation requirements as described in the European Medical Device Regulation – EU MDR . 
What is meant by the term ‘clinical evaluation’ in the EU MDR? 
The EU Medical Device …


ISO 22442 – Medical Devices containing animal materials

Certain medical devices utilize animal materials in their manufacture to provide performance characteristics that are more advantageous than non-animal-based materials.

The use of animal material, however, carries the risk of transmitting infectious diseases when it is improperly collected, stored or …


Brexit and Medical Devices Regulation in the United Kingdom

On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance on how medical devices will be regulated in the UK from 01 January 2021, following the UK departure from the European Union.

What does this …


Medical Device Regulation (MDR) – 11 Key Changes

The EU Medical Device Regulation (MDR) was the most significant regulatory change in Europe in over 20 years.

The MDR entered into force in 2017 with a three-year transition period.*
The MDR replaced the Medical Device Directive 93/42/EEC and …


Software as a Medical Device (SaMD)

SaMD: A need for Regulatory Reform in Australia
In February 2019, the TGA issued a consultation for feedback from industry on how Software as a Medical Device (SaMD) is regulated in Australia. Currently, SaMD is regulated under the existing medical …