Understand how your MDR submission will be read, before a notified body reads it
B+ Solutions is an independent regulatory practice for medical device manufacturers working through EU MDR technical documentation and clinical evidence. It is built on more than a decade inside the medical device regulatory ecosystem, including the conformity assessment side. Advisory services open in 2027. Until then, B+ Solutions shares practical insight from that same perspective.
Built from both sides of the submission
Most regulatory guidance is written from one side of the table. B+ Solutions is built from both. More than a decade of work across medical device manufacturers and the conformity assessment side means your documentation can be understood against the way it will actually be assessed, not against a generic checklist. The result is honest, structured feedback that surfaces the gaps a notified body is most likely to raise, while there is still time to fix them
What B+ Solutions will offer
Advisory services open in 2027. They will stay deliberately focused on two areas where independent, review-side input makes the biggest difference.
Technical Documentation Review
Independent, fixed-scope review of EU MDR technical documentation, including gap assessment. Structured feedback, clear risk flags, and a prioritised view of what a notified body is most likely to question.
Clinical and Post-Market Evidence
Review and structuring of clinical evaluation documentation (CEP, CER, SSCP) and post-market documentation (PMS, PMCF), assessed for the gaps that most often weaken an MDR submission.
Insight from the review side
Until services open, B+ Solutions publishes practical analysis on EU MDR, technical documentation, and clinical evidence. The focus is on patterns that actually show up in review, not generic regulatory commentary.
Be ready before 2027
Join the waitlist to hear when advisory services open, and to receive occasional insight on EU MDR documentation in the meantime.
