London twilight
Poole, into London
A close friend called, asked if I could meet him in London today on a personal matter. Of course, anything, let me get the train in. I pick up a flower and a some fizzy water before heading out.
I’d planned a day along the beach, long overdue. A storm surf would have been wonderful, white foam and booming breaks, but the early morning was placid along the harbor and the beachfront. Still, lovely to walk the sands and share the morning with the couples and dog-walkers.
Right. 9 am: hit the roads north. On arriving in Basingstoke, though, there were a few adjustments. There is no more cruel word in Dutch than snelbus. The British equivalent is Replacement Bus, evident only after I’d paid for parking. When track works are on, the transit times double.
In this case, the delays start with waiting for an onwards bus, and end with further 45 minute waits for a train in Woking. Still, it’s a chance to see the place, and, in my case, to find the landing spots for Wells’ Martians. They are well remembered in the city: a landing spot near the mall, the mechanical tripod striding along the thoroughfares.
All in all, five hours to London, car, bus, and train. And there will be an equal measure back for the evening. Still, the visit with the family in St. Thomas meant a lot for all of us. Between conversations, there were moments free for walks along Southbank. A small food fair, a burst of rain, a lot of tourists to study.
‘not a terrible trade for the day on the beach.
Making the Milestone
Our Technical File was submitted to our Notified Body today.
I know, it’s one of those ‘What did he just say?’ statements. A bit of background, then:
Medical Devices in Europe do not enter the market until they conform to the European Medical Device Directive. Each country has a standards group, the Competent Authority, which sets the rules for approving devices, and those rules are applied to individual products by the Notified Body.
The Notified Bodies are commercial organisations who audit the paperwork systems that companies must set up to create and produce product (the Quality System), inspect manufacturing facilities (granting ISO 13485Approval), and judge the evidence portfolio (the Technical File) that documents a product’s safety and effectiveness. In the latter case, the review leads to granting of a CE mark, which allows the product to be sold to physicians and to hospitals.
The Technical File is a large and detailed document: ours runs nearly 100 pages and references over fifty standards and nearly 200 supporting documents. 
We had a half-dozen people and a handful of supporting test facilities in the US, UK, and France engaged for six months to perform the final testing and write the submission.
We kept an aggressive schedule and produced a very high-quality report. It will be some time before it is fully reviewed and we get approval, but this is the milestone that bridges R&D to marketing and sales, transforming a project into a business. ‘Many thanks and a lot of credit to our employees and contractors, our investors and our partners who have have worked together to achieve this inflection point.