Navigating regulatory requirements to deliver products on-time.

The regulatory submission process can be long and expensive. We employ regulatory experts who know both the compliance and the technology to ensure you can deliver your product to market on time and in budget.

Medical Compliance*

*without the stress

Navigating the myriad of regulatory requirements for medical device products doesn't have to be difficult. With deep knowledge of compliance standards and bespoke technology solutions, our team of regulatory engineers make the process a breeze and help you get your product to market quickly and cost-effectively.

How can we help?

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.

How can we help?

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.

ON AVERAGE, MEDTECH COMPLIANCE COSTS 6X MORE THAN ANY OTHER NON-MEDICAL SECTOR *

*NOT WITH US

JUST ASK OUR CUSTOMERS

  • Produced DHF for certified medical device within just 6 months.

  • Developed a strategy that targets two countries with one product for approval in USA and EU

  • Built a usable QMS, and development strategy that allows customer to build upon for next releases

  • Using tento manager, we streamlined the testing cycle to just 2 weeks, months ahead of schedule

Dr Nicola Thorn, CEO

``The large disparity between the world of agile technology and medical regulations is only getting bigger, both practically and philosophically. IEC 60601-1, for example, holds over 400 individual clauses, each with detailed requirements for approval, and this is just one part of a wider IEC60601 standard which includes over 50 others!

We at AND have worked with customers over 40 years to turn pioneering ideas into reality, and are dedicated to providing clear, upfront guidance in navigating the hurdles around MedTech regulation.``

Dr Nicola Thorn is an expert technologist, regulatory consultant and software specialist. She has extensive knowledge on technology medical compliance standards including 60601, 62304, 82304, 62366 and more. Nicola is also a mentor on the NHS Clinical Entrepreneur Scheme, helping innovators in the NHS bring their medical devices to life.

CUSTOMER CASE STUDY

  • Developed and deployed a connected energy management across the UK within 6 months, halving anticipated development times.
  • Developed a proof of concept for a connected elderly fall sensor within just two weeks.
  • Proven blocks of technology to accelerate the development cycle.

How do we ensure customers meet all the necessary compliance requirements every time?

tento test manager

+

know-how

By drawing on our long history in heavily regulated markets, our inhouse knowledge, and our revolutionary tento testing manager, we guide our customers through their personal regulatory journey, ensuring all technical file content and evidence is in place along the way. We can quickly generate design history files, and author documentation, as well as aid in the submission process where needed

What is Tento?