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EXPERTISE

Pre-Compliance Gap Analysis

Identify and address regulatory gaps in your programme to facilitate efficient development, ensure compliance and maximise your chances of product success.

Remove uncertainty from your compliance journey

Bringing a medical device or product to market requires meeting strict regulatory standards. Our Pre-Compliance Gap Analysis service is tailored to alleviate this burden by systematically evaluating your product’s design, documentation, and processes against relevant standards. This proactive approach uncovers discrepancies that could lead to non-compliance, allowing for timely corrections and reducing the risk of costly delays during formal compliance testing.

At eg technology, we work closely with your team to review your design, code, documentation, and processes against the relevant regulatory requirements, including ISO 13485, IEC 60601, ISO 14971, IEC 62304 and more. This ensures a thorough assessment that aligns with your product and market sector.

Streamline your product’s compliance

Our team of experts brings a wealth of experience across various sectors, including medical devices, laboratory equipment, and consumer products. We conduct thorough assessments that align with your specific product and sector requirements. Our service includes:

Benefit from early insight and proceed with confidence

Engaging in our Pre-Compliance Gap Analysis offers several advantages:

Maximise your chance of product success

With years of experience in product development, we understand what it takes to achieve compliance efficiently. Our structured approach helps you mitigate risks, streamline approvals, and avoid last-minute surprises.

Partner with eg technology for your Pre-Compliance Gap Analysis and ensure a smoother path to product approval and market success.

We can tailor any Gap Analysis based on your needs and budget and as such, the estimate for our review package will depend on the scope of the review and any budget constraints.

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Pre-Compliance Gap Analysis

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Other Expertise

Working with eg technology was instrumental in creating the next generation of Sentimag® device. The team at eg were a great fit for us from the start and they worked diligently to realise our requirements. They delivered a device to us that performed well and exceeded expectations. Receiving our FDA approval was testament to eg’s stringent and considered product design and development process.

EndomagQuentin Harmer, CTO

Being able to trust our innovation to a development partner who plugged into our team seamlessly was beyond reassuring. They delivered a product which not only performed well, but was compliant to the specified requirements, facilitating our market launch in October 2022. We are proud that this product is already allowing business customers to reduce their electricity bills by at least 20%.

measurable.energyJosh Eadie, CTO

The work eg technology did was important in many respects. The ideation and initial bench testing helped us quickly determine whether there was a feasible solution that could be readily applied in the market. The prototype not only proved that the solution actually worked technically, but also it allowed us to demonstrate this to potential customers and get their acceptance that this was a real world solution for them. It was this traction which was key to raising the finance to continue to develop the product and ultimately start to build a commercial fleet.

eBarNick Beeson, Managing Director

It was a real pleasure working with the engineers at eg technology. Their work inspired and enabled us to develop fully recyclable packaging solutions for 98% of our diverse range of instruments, exceeding not only our own expectations but also delighting our global customer base.

Duckworth & KentEoin Henry, Digital Marketing & IT Supervisor

Working with eg technology has significantly increased our work efficiency, both now and in the future. We were able to describe our application and trust the team at eg to define specifications, develop concepts, and deliver a prototype. This allowed our team to focus on our own areas of strength.

Genome Research Ltd | The Wellcome Sanger InstituteOmer Bayraktar

I had the privilege to work with the eg team, albeit for a short period of time. We had requested a review of our design which the eg team did diligently and highlighted key areas for design updates. It is wonderful to meet a company who not only understand how to design products that address patient safety but are also able to communicate the design thinking behind it. I look forward to working with eg again in the future.

CNS Therapy, AGMarc Mathys, President

It is never easy to integrate the conflicting requirements of biochemistry, electrochemistry and engineering in any project, but I was very impressed with the breadth of capabilities eg technology brought to the project. Close integration with the team here at Vantix led to a smooth and efficient interface.

Vantix DiagnosticsAndy Gover, Director

eg technology delivered an injection of creativity and consumer product know-how that we, as a technology start-up, couldn’t provide in-house. We had the technology and an idea of how we wanted the hardware to work, but eg technology took these elements and turned them into a desirable consumer product that we were able to successfully take to market.

Cambridge Temperature ConceptsDr Oriane Chausiaux, Director

We were very happy with the work that eg technology did and would work with them again without hesitation.

Avacta Animal HealthAlastair Smith, Director

We are very happy with the work that eg technology did for us. We are already using the rig to improve the validation process for our optical sensors and as a result increase customer satisfaction.

Sylex Fiber OpticsPeter Löwy, Director

We selected eg technology because they seemed to be the most pragmatic and focused of the companies that we had discussed the project with. They did not let us down. At every stage they offered practical solutions and a workable programme – always a priority when you are a smaller company. They consistently delivered on time and came up with really innovative ideas and solutions to deliver for us.

Wessex MedicalSarah Smith, Director

eg technology’s work was instrumental in automating the Parsortix system so that patient blood can be processed efficiently using ANGLE’s patented Parsortix technology to capture CTCs. This was a major step forward in bringing the Parsortix technology to market.

Angle PlcAndrew Newland, Director