Navigate the complex world of medical device regulations with confidence

Consulting for advanced medical technologies

We have a 100% success rate in helping our clients achieve device certifications to EU MDR 2017/745 and US FDA 510(k).certification in addition to management systems including ISO 13485 (Quality Management Systems), ISO 27001 (Information Security Management Systems) and ISO 14001 (Environmental Management Systems).

We are specialists in all aspects of device development, risk management, cybersecurity, software development and usability engineering. Our experience covers electrical medical equipment, medical imaging, digital heath technologies, Mobile Medical Apps, Software as a Medical Device (SaMD), AI/ML technologies, implantable devices, in-vitro diagnostics, surgical robotics, therapeutic devices and surgical instruments.

Efficient Compliance

We have a 100% success rate in helping our clients achieve ISO 13485 Certification.

We have partnered with leading document management software provider Cognidox to create Daedalus compliance path, a cost effective eQMS with affordable monthly payment options available and offering state-of-the-art procedures and templates in design control, risk management, usability engineering and software development.

Our eQMS is built on 30 years’ experience developing complex medical devices and is designed to comply with EU, UK and US regulations in a lean efficient manner.

Further details can be found here.

"As a seed-stage start-up commercialising an innovative cloud-based SaaMD for calculating coronary inflammatory burden, UOVO helped us rapidly implement a QMS that not only helped us with our first 510(k) filing and 13485 certification but also efficiently supported our CI/CD-based development practices."

- David Schottlander, CTO, Caristo Diagnostics

“Peter (UOVO) helped us navigate the complex world of medical device regulations and we would not hesitate to recommend him to any start-up looking to understand their options, how they can plan ahead and make sure they are on the right path.”

- Wesley Fogel, CEO, On the Mend

“I have found Peter at UOVO to be highly knowledgeable. This has been particularly so in areas where technology or regulation is new or developing – in such areas Peter’s insights and solutions-oriented approach have been highly useful.

I’d recommend Peter for any medical device project which is innovative in any form."

- Chris Hannan, VP QA/RA Vision RT

“Peter at UOVO provided valuable recommendations into the practical application of medical device regulation. He quickly developed an understanding of our software and its use, provided hands-on support and helped us with the validation plans of our software. I would recommend him to any business developing complex medical device software and process software used to manufacture medical devices."

- Mac Tuncer, Founder & MD, Meshworks

Testimonials

Our Services

  • Development of Management Systems tailored to your needs. ISO 13485 (Medical Device QMS), ISO 27001 (Information Security Management Systems) and ISO 14001 (Environmental Management Systems)

  • Creation of Technical Documentation including Clinical Evidence, Risk Management and Usability Engineering.

    EU/UK/US regulatory submissions.

  • A clear device development roadmap enables accurate estimation of timescale and resource requirements. We combine an in-depth knowledge of regulation with 30 years' experience bringing complex medical device to market.

  • We can improve confidence in certification audits and eliminate the risk of delays and increased cost due to rework through our collaborative audit process. Mock audits conducted by an ISO 13485 lead auditor with a Notified Body.

  • It is a legal requirement that employees engaged in development of a medical device have adequate training required for them to do their job. We can help fulfil this requirement by providing bespoke training packages.