The problem:

The last 10 years has seen a significant leap forward in terms of the availability of computing power and their integration into medical devices. This has allowed for significant improvements in patient care, with the computer processing power of typical implantable cardiac rhythm management systems now exceeding that of the Apollo moon missions.

This trend is expected to accelerate, both because of the performance and safety improvements software offers to individual medical devices, but also because of the integrated, data-hungry nature of the ‘AI promise’ to solve bigger healthcare questions.

What has not kept pace with this exponential growth is the specialist skills required to deliver it in a safe and effective way and in line with regulatory standards. As a consequence, many MedTech start-ups fail to fully understand and implement these development standards, make poor platform and development decisions and risk significant regulatory delays and rework costs.

Our solution:

We can offer tailored support to your company, to complement your existing efforts.

This could include

A full range of IEC62304 compliance support, including

  • a. Providing advice to existing software management on how to make their SDLC processes compliant with IEC62304
  • b. Improvements of existing SDLC to make those IEC62304-compliant by identifying process gaps
  • c. Establishment of an IEC62304 compliant Software Development Life Cycle (SDLC) process from scratch with complete software traceability from requirements to implementation and test
  • d. Providing IEC62304 and SDLC training to relevant personnel
  • e. Overseeing IEC62304-compliant process being executed in the company
  • f. Providing royalty-free documentation IEC62304-compliant templates and creating project documentation based on it

Software design and implementation support in accordance with IEC62304

  • a. Creating software requirements based on high-level project/system requirements
  • b. Designing software Architecture and corresponding software plans
  • c. Design of software Configuration Items
  • d. Assisting in development of Embedded software for your system

Software development/business integration support

  • a. ISO13485 support for the software elements and establishing an active link between QA/Regulatory and Software organisations within the company.
  • b. Advising on necessary Verification & Validation (V&V) activities for the software team
  • c. Advising on IEC60601 software-related items.

Further support

  • a. Whenever needed by a client, acting as a software manager and drive the product to successful regulatory submission – either full- or part-time.
  • b. Advice on necessary tools and infrastructure.
  • c. Advice on necessary skillsets within Software and Test teams
  • d. Interacting with customer-selected software suppliers and 3rd-parties.
  • e. Advice on SOUP and development tools selection; assisting in validation for use
  • f. Assistance in design of Embedded software configuration items.

These services are designed to establish IEC62304-compliant processes within prospective client’s software team, build “safety-critical” culture amongst developers and lead to successful product submission/certification within MDD/MDR (also IVDD/IVDR) and/or FDA 21 CFR 820

The following operating models are offered, ranging from ad hoc to near full-time support.

  1. Full turnkey solutions: build the SDLC process from scratch and drive it to successful submission.
  2. Corrective action support: analyse the state of existing SDLC, software and documentation, propose corrective actions and oversee its execution.
  3. Advisory mode: providing an ad-hoc advice whenever required

Here’s the sample of Medical projects we’ve been working in the past

Osler In-Vitro Diagnostic device

Osler Diagnostics
Osler Diagnostics is an innovative company that is developing a ground-breaking Point of Care In-Vitro
diagnostic device. We were asked to join the project to assist the company in the following areas:
– IEC62304-compliant Software Development Life Cycle creation
– SDLC integration with ISO13485 QMS
– ISO14971-compliant software risk management
– Software Architecture design
– The Embedded software design and development
These tasks were completed to customer satisfaction and although the development is still in progress
there is no doubt that the project is going to be a success.
  • Categories: Medical/Healthcare
  • By : admin
  • Created on: November 23, 2020

Creavo Vitalscan, Corsens

Creavo Medical
During our founder’s employment period with Creavo, the two major projects achieved significant milestones.
Firstly, there was the Creavo Vitalscan, the first-generation Magnetocardiography Medical Device.
During the course of the project the following goals were achieved:
– Complete IEC62304- compliant SDLC creation
– SDLC integration with ISO13485-certified QMS
– Development of a complete set of documentation needed for FDA software certification to Class B.
– Successful FDA certification 510(k)
The second device from Creavo is called Corsens and is built up on the success of the Vitalscan, making it
better, easier to use and more advanced in terms of its diagnostic capabilities. The following goals were
– Creation of new system architecture
– Design of a complete set documentation needed for CE marking and FDA certification
– Design and development of the Embedded Software in accordance with Class B requirements
– ISO14971-compliant software risk management
– Overall software project management
With these significant achievements there is no doubt that Creavo will be able to finalise the
development of the Corsens platform and gain significant market share on the Magnetocardiography
market. Their development will be continuing to help Emergency Departments to rapidly rule out
patients with non-heart related conditions, thus accelerating the provision of the healthcare.
  • Categories: Medical/Healthcare
  • By : admin
  • Created on: November 23, 2020

LumiraDx Point Of Care device

LumiraDx is known for their highly advanced connected diagnostics and diagnostic-led care solutions
that are designed to enable more effective and cost-efficient patient care.
The following goals were achieved:
– Creation of new generation platform software concept
– Design and development of several drivers for the Point of Care device
We believe that the system designed by LumiraDx is one of the most advanced and innovative systems
on the market and we hope that the company will go from strength to strength.
  • Categories: Medical/Healthcare
  • By : admin
  • Created on: November 23, 2020

Alere Reader

Alere (now Abbott)
The project began as Alere Inc Reader, an innovative Lateral Flow device reader, designed for Point of
Care market. The project ran from start to finish (or from inception to production) and was completed in
record time – 9 months for the first variant of the device and additional 14 months for the advanced
connected system.
The following goals were achieved during the project:
– Complete IEC62304- compliant SDLC creation
– SDLC integration with ISO13485-certified QMS
– Development of a complete set of documentation needed for FDA software certification to Class
– Creation of basic (first-gen) and advanced (second-gen) of the device architecture
– Design and development of Embedded software
– ISO14971-compliant software risk management
– Assistance in IEC 60601 certification (EMC/EMI)
– Creation of Production EOL software
– Integration of Production EOL Test software with manufacturing facility
Once Abbott Laboratories acquired Alere Inc, the product was renamed to Abbott Digival and is available
for purchase on a variety of markets worldwide.
  • Categories: Medical/Healthcare
  • By : admin
  • Created on: November 23, 2019