Are you looking for your device to be certified to a technical standard? Our expert engineers have a detailed knowledge of the compliance requirements behind electronics and software based products, and can review, test, and confirm compliance to key medical standards such as IEC60601 and IEC62304.

We can provide test plans, test jigs, test reports, and technical documentation that you need to meet the regulations required for product release. With 40 years of development under our belt, we are a safe pair of hands – ensuring your innovation is safe and ready for use.

No matter what the device or country of submission, implementation of a compliant quality and risk management process is a vital step in the development of your device. Creating an extensive and complete process from scratch can seem daunting, but our expert advisors are here to provide clear, actionable guidance and helping hand where they are most needed.

We provide QMS templates, SOPs and test records, as well as detailed gap analysis and documentation reviews to tackle your risk requirements head-on. We also provide FMEAs, facilitate risk registers and supervise scoring sessions to track and document your risk controls and hazard mitigation measures

Need help in creating your design history file, or supporting technical file documentation? Our team contains both experienced engineers and compliance experts that can translate technical information into audit ready documentation.

We author your system documentation, software architecture document, product, market and technical requirements, as well as design and development plans. We can also run third-party test, produce testing plans and reports and certificates of compliance ready for your submission. 

Are you looking to submit your medical device for approval under the FDA, EU or UK regulations? Are you developing one product for all three markets?

With the help of our regulatory experts, we can ensure you meet the requirements of all three through both strategy settings and delivery. By adopting the right strategy from the start, you can plan you development cycle, technology evaluation plans to ensure you cover all aspects of the regulation. We can aid you in documentation authoring and test evidence that is applicable across multiple jusidictions.

We provide test plans, test records, test reports, technical documentation, risk management files, usability engineering files, SOPs and QMS processes.