Regulation

Article 61 Clinical Evaluation in the EU MDR

Article 61 Clinical Evaluation in the EU MDR

Manufacturers must plan, carry out, and document a Clinical Evaluation in order to comply with the general safety and performance standards outlined in Annex I, as per Article 61. Clinical evaluation is a series of ongoing activities that use scientifically reliable techniques for the evaluation and analysis of clinical data in order to confirm the safety, clinical performance, and/or effectiveness of the medical device when used in accordance with the manufacturer’s instructions.

Cybersecurity for medical devices in Europe

Cybersecurity for medical devices in Europe

Cybersecurity for Medical devices is advancing, and the use of software medical devices is also increasing daily. The increased interconnection of medical devices to computer networks and technological convergence have made devices and software programmes vulnerable to mishaps. With the advancement of software as a medical device, proper regulations must establish the safety and security of medical devices.

IMDRF Regulation on SaMD

IMDRF Regulation on SaMD

IMDRF Regulation on SaMD: As more businesses see the benefits of utilizing their software development knowledge for the benefit of patients throughout the world, the market for software as a medical device (SaMD) is expanding quickly.

Smart Wearables Regulations in the EU 

Smart Wearables Regulations in the EU 

Smart wearables technology is gearing up to great potential and becoming a part of our daily lifestyle. While most of them are claimed to fall under general wellness equipment, there is a rising concern about how these devices are regulated in terms of safety without falling under the stringent medical device regulations.