From day one to market and beyond, one accountable partner

Whether you are building a company or bringing a product to market, you have to move quickly and still satisfy regulators and investors. We give startups, SMEs, and scale-ups the compliance foundations to start strong, and lead your product through development, transfer, launch, and post-market. Compliance, quality, and delivery stay aligned at every handover, without expensive rework.

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What we offer

How we help your team

Practical, hands-on support, shaped around your products, your team, and the outcomes you need.

Compliance and risk foundations
We set up right-sized quality systems with ISO 14971 risk management built in from the start. Controls fit your stage and budget, scale as you grow, and keep decisions traceable through post-market.
Early regulatory strategy
We map the fastest defensible route to approval for your product and markets. Early clarity keeps development focused and funding conversations grounded.
Investor and due-diligence readiness
We prepare the quality, regulatory, and operational evidence investors and partners look for. Clean systems shorten due diligence and build confidence.
Design control and technical documentation
We build and maintain design history files, technical files, and design controls that meet EU MDR, IVDR, and FDA expectations. Documentation stays audit-ready as your product evolves.
Senior QA, RA, and project leadership
We lead cross-functional projects from development through transfer and launch, with senior QA and RA leadership on a fractional basis. One accountable partner keeps scope, budget, and timeline aligned, without the full-time cost.
Technology and site transfers
We plan and run technology transfers between sites and partners without losing control of quality. Risk is managed up front, so supply and compliance hold through the move.
Market entry and launch readiness
We plan market entry around real milestones and constraints, then prepare the quality, regulatory, and operational pieces your launch depends on. Nothing that matters is left to the last minute.
Post-market surveillance and vigilance
We set up post-market surveillance, complaint handling, and vigilance reporting that keep you compliant after launch. Field signals feed back into the product, not just the file.
Scale-up support
We help you grow systems, teams, and processes without breaking compliance. What worked at 10 people is redesigned to work at 100.