Are you looking for your device to be certified to a technical standard? Whether its software– based, electronics, or both, our expert engineers have a detailed knowledge of the compliance requirements, and can review, test, and confirm compliance to these key standards.
We can provide test plans, test jigs, test reports, and technical documentation that you need to meet the regulations required for release.
No matter what the device, or the country of submission, you will need to implement both quality and risk management process throughout the development of your device. Implementing quality or risk management can seem daunting, but our expert advisors can provide clear, actionable guidance and helping hands.
We can provide QMS templates, SOPs, templates and records as well as perform gap analysis reviews, perform documentation reviews. We can provide FMEAs, aid risk registers and scoring sessions as well as tracking and documenting your risk controls and hazard mitigation measures
Need help in creating your design history file, or technical documentation? Our team contains both experienced engineers and compliance experts that can translate technical information into audit ready documentation.
We can 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 aide you in documentation authoring and test evidence that can be re-used across the different areas.
We provide test plans, test records, test reports, technical documentation, risk management files, usability engineering files, SOPs and QMS processes.
Are you looking for your device to be certified to a technical standard? Whether its software– based, electronics, or both, our expert engineers have a detailed knowledge of the compliance requirements, and can review, test, and confirm compliance to these key standards.
We can provide test plans, test jigs, test reports, and technical documentation that you need to meet the regulations required for release.
No matter what the device, or the country of submission, you will need to implement both quality and risk management process throughout the development of your device. Implementing quality or risk management can seem daunting, but our expert advisors can provide clear, actionable guidance and helping hands.
We can provide QMS templates, SOPs, templates and records as well as perform gap analysis reviews, perform documentation reviews. We can provide FMEAs, aid risk registers and scoring sessions as well as tracking and documenting your risk controls and hazard mitigation measures
Need help in creating your design history file, or technical documentation? Our team contains both experienced engineers and compliance experts that can translate technical information into audit ready documentation.
We can 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 aide you in documentation authoring and test evidence that can be re-used across the different areas.
We provide test plans, test records, test reports, technical documentation, risk management files, usability engineering files, SOPs and QMS processes.
tento test manager
know-how
By drawing on our long history in heavily regulated markets, our knowledge, and our revolutionary tento testing manager, we guide our customers through the regulatory journey, ensuring we capture all the test evidence, compliance documents along the way. We can quickly generate design history files, and author documentation, as well as aid in the submission process.