End-to-end device delivery: concept to cleared product.
For manufacturers who want a complete solution — not a team to manage — our turnkey development programme covers engineering, regulatory, testing, manufacturing liaison, and submission. We deliver a market-ready device, not a pile of files to sort out.
Turnkey development is the engagement model for clients who need a complete working medical device — with all regulatory documentation, test reports, and market clearances — but who do not have or do not want to build an in-house development team. We take the project from concept brief through to a cleared product handed over with its complete technical file, regulatory approvals, and manufacturing transfer package.
The engagement is structured around defined phases with client approval gates: concept definition and regulatory strategy, design and development, verification testing, regulatory submission, and manufacturing transfer. Each phase produces defined deliverables, and the client approves each gate before the next phase begins. There are no surprises in scope or cost between gates.
We act as the principal contractor for all technical and regulatory activities. Where specialist subcontractors are required — biocompatibility laboratory, sterilisation validation, clinical trial organisation — we identify, brief, and manage them. You have one team to manage, not six.
Detailed phase-by-phase project plan with defined deliverables, timelines, and fixed pricing per phase so the total investment is known before work begins.
One named programme manager accountable for all technical and regulatory workstreams, with weekly status reporting to your leadership.
Full technical documentation file structured for your target markets — EU MDR Annex II, CDSCO, or FDA — delivered as a living document throughout the programme, not assembled at the end.
Regulatory submissions prepared, filed, and managed through to approval, including regulator query responses, with your team kept informed but not burdened with submission management.
A device that cannot be manufactured repeatably is not a product. Manufacturing requirements are considered from the first design review — material specifications, process capability, incoming inspection criteria, and manufacturing test requirements are built into the design output documentation. When the design is ready for transfer, the manufacturing package includes all the information a contract manufacturer needs to produce the device to specification.
We support contract manufacturer selection and qualification, preparation of the Device Master Record (DMR) or Device Master File, manufacturing process qualification (IQ/OQ/PQ where applicable), and the first article inspection process. For devices requiring sterilisation validation, we coordinate EO, gamma, or other process validation in accordance with ISO 11135, ISO 11137, or ISO 17665.
We can also advise on India-based contract manufacturing options for clients targeting the CDSCO market, including assessment of GMP compliance and loan licence structuring under MDR 2017 Rule 37.
Complete manufacturing documentation package including BOM, assembly procedures, incoming inspection criteria, process parameters, and finished device acceptance testing.
Assessment and qualification of selected contract manufacturer including QMS audit, process capability review, and first article inspection.
Specification and management of sterilisation process validation (EO, gamma, or other), including laboratory selection, dose audit or cycle development, and validation report review.
Complete transfer of all technical and manufacturing documentation to the contract manufacturer, with on-site training and witnessed first production run.
The regulatory submission is built continuously throughout the programme — not assembled from scratch at the end. By the time verification testing is complete, the technical file is substantially ready. This eliminates the 3–6 month gap between "device works" and "regulatory submission ready" that is common in programmes where documentation is treated as an afterthought.
We prepare all submission artefacts for target markets, manage the review process, respond to regulatory queries, and receive the approval. For CE Mark, we manage notified body liaison from technical file review scheduling through to certificate issuance. For CDSCO, we file via SUGAM and manage the complete correspondence cycle. For FDA, we submit via the Electronic Submissions Gateway and manage the review clock.
Technical file built and updated at each design phase gate, so submission preparation is a final review and format check, not a documentation sprint.
Simultaneous submission management for all target markets, with a single programme manager coordinating regulator interactions and keeping timelines aligned.
Complete handover package including all approvals, post-market surveillance obligations, QMS maintenance requirements, and a regulatory calendar for the first two years on the market.
Ready to move forward?
Describe the device you want to bring to market and the markets you are targeting. We will outline a turnkey programme with phase-gate pricing within two weeks.
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