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

  • In-Vitro Diagnostics device (productization of a Proof of Concept, creation of IEC62304 framework)
  • Magnetocardiography device for Coventry-based client (from Proof of Concept to certification (Gen1))
  • Creation of software documentation for regulatory submission for several clients
  • Development of 2 generations of Point of Care diagnostics device for US company