MDR Readiness Superpack

MDR changes require careful review, planning and updates to ensure you remain compliant with the new requirements.

Software Validation Superpack

Validating medical device software can be challenging, especially when the software is a component part of or is embedded within a more complex medical device.

Human Factors and Usability Engineering Combo

Make your medical device easy and safe to use. Easily comply with global regulatory requirements and expectations.

UL 2900 Medical Device Cybersecurity Checklists

Protect your medical device from hackers and easily get regulatory clearance in global markets (incl. US, EU, and Canada).