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Who we help

If you need to reach or stay on the market, you are who we help

Three situations come to us most. The starting point differs. The job is the same: a file that passes and a market that stays open.

01

Foreign manufacturers entering the UK and EU

You make a strong device abroad, but Britain and Europe are a wall of rules, two separate regimes since Brexit, and the wrong first step can cost you a year.

How we help

  • We become your UK Responsible Person and EU Authorised Representative, on one contract.
  • We register your devices with the MHRA and in EUDAMED.
  • We hold your technical file and stand as your point of contact for both regulators.
02

SMEs and startups chasing CE, MDR or FDA

A first approval can make or break a young company. Get the file wrong and you pay twice, or miss the window that the whole business plan depends on.

How we help

  • We build the technical file right the first time, to the evidence bar the regulation now expects.
  • We set the Notified Body and classification strategy before you spend on the wrong path.
  • We keep it lean so a startup budget is not burned on rework.
03

Established makers facing a deadline

MDR, IVDR and EUDAMED dates are closing in on a portfolio that already sells. A gap on the market is lost revenue and lost trust.

How we help

  • We run a gap analysis against the new regulations and turn it into a remediation plan.
  • We build the clinical and performance evidence the transition demands.
  • We sequence the work against the real deadlines so nothing falls off the market.

Not sure which one is you?

That is what a free consultation is for. Fifteen minutes tells you where you stand and what the route looks like.

Book a free consultation Start with a Gap Assessment