Engineering and product development services.

We specialise in navigating the journey between an early prototype and a market-ready, commercially sustainable, professionally manufactured product.

Whether you need a strategic reality check on your current design or end-to-end technical leadership to get you to production, Systolic provides the pragmatic expertise to get it done.

While we can partner with you at any stage of the development cycle, our services are optimised for the critical phases following your initial proof-of-concept:

Feasibility reviews:

We evaluate your existing prototype against technical, commercial, and manufacturing targets, identifying design gaps early so you don't waste time and capital on unscalable ideas.

Regulatory & Compliance:

Particularly for medical and electronic devices, safety and security compliance cannot be an afterthought. We align necessary regulatory requirements, certifications and documentation alongside the feasibility, development and testing phases to prevent costly late-stage delays.

Prototyping & Testing:

We iterate and refine your design based on robust testing data. We ensure your product functions reliably under real-world conditions and meets user expectations as well as strict industry standards.

Technical project management:

We bring 25 years of accountability and proven processes to your project, acting as an extension of your team to keep the development pipeline moving efficiently.

Design for Manufacture (DFM):

A working prototype is not always a manufacturable product. We’ll work with you to refine your product architecture, material selection, and assembly processes for cost-effective, reliable production at the appropriate scale for your business model.

Medical device undergoing EMC testing in anechoic chamber, demonstrating regulatory compliance and electromagnetic compatibility validation.

Ready for regulatory scrutiny.

We have experience of navigating regulatory pathways for many product types, but specially deep experience for medical devices. Systolic can help make sure that your products, its documentation and its manufacturing process can deliver against global medical device standards including:

Medical Device Files / Technical Files (ISO 13485, FDA QMSR)
Medical Device Risk Management (IEC 14971, AAMI TIR57)
Electronic Medical Device Standards (IEC 60601 series, AAMI TIR69)

Engaged across your product development pipeline:

Pipeline stage	Your activity	Our activity	Strategic focus	Regulatory alignment
Concept and Feasibility	Identifying the need and setting the vision. Ideation, user research, early brainstorming and early prototypes.	High-level technical review, early risk identification, and evaluating fundamental science behind the idea.	Establishing strong fundamentals to build on, and avoiding common pitfalls.	Early identification of potential regulatory pathways and standards.
Iterative Prototyping and Design for Manufacture	Defining product requirements and facilitating end-user feedback.	Product architecture, CAD refinement, engineering development, and building robust, functional prototypes.	Continually evolving, testing and improving the design against performance, safety and manufacturing requirements.	Identifying and planning necessary certifications and compliance tests based on the product's function and intended use. Establishing product technical file and risk management documentation.
Testing (Design Verification and Validation)	Organising field testing (e.g clinical studies) of prototypes. Validating the product with stakeholders.	Developing and executing test protocols, preparing representative products for tests and clinical studies, documenting test outcomes.	Proving that the design and its production processes can consistently meet product requirements and user needs.	Ensuring test activities and documentation clearly demonstrate that products meet all relevant industry standards required for market access.
Manufacturing Transfer	Preparing for production funding and launch.	3D CAD optimisation for tooling (e.g., injection molding), creating technical drawings, finalising the Bill of Materials (BOM), and supplier liaison.	Optimising the product architecture for cost-effective, reliable, and repeatable mass production.	Finalising compliance documentation, risk management files, and quality checks for market release.

Engaged across your product development pipeline:

Pipeline stage	Your activity	Our activity	Strategic focus	Regulatory alignment
Concept and Feasibility	Identifying the need and setting the vision. Ideation, user research, early brainstorming and early prototypes.	High-level technical review, early risk identification, and evaluating fundamental science behind the idea.	Establishing strong fundamentals to build on, and avoiding common pitfalls.	Early identification of potential regulatory pathways and standards.
Iterative Prototyping and Design for Manufacture	Defining product requirements and facilitating end-user feedback.	Product architecture, CAD refinement, engineering development, and building robust, functional prototypes.	Continually evolving, testing and improving the design against performance, safety and manufacturing requirements.	Identifying and planning necessary certifications and compliance tests based on the product's function and intended use. Establishing product technical file and risk management documentation.
Testing (Design Verification and Validation)	Organising field testing (e.g clinical studies) of prototypes. Validating the product with stakeholders.	Developing and executing test protocols, preparing representative products for tests and clinical studies, documenting test outcomes.	Proving that the design and its production processes can consistently meet product requirements and user needs.	Ensuring test activities and documentation clearly demonstrate that products meet all relevant industry standards required for market access.
Manufacturing Transfer	Preparing for production funding and launch.	3D CAD optimisation for tooling (e.g., injection molding), creating technical drawings, finalising the Bill of Materials (BOM), and supplier liaison.	Optimising the product architecture for cost-effective, reliable, and repeatable mass production.	Finalising compliance documentation, risk management files, and quality checks for market release.

Project based, cost conscious.

Innovative product development is exciting and unpredictable, but working with Systolic can reduce your known unknowns, as we work with you to define and plan fixed price work packages wherever we can.

We’ll collaborate wherever you are in your product journey to bring it to market. If you need rigour and professional direction in your technical team, get in touch today.

Start a conversation

Cutitronics handheld skincare device range showing refined industrial design and user interface development.