Who do you work for?
Three groups. First, medical device manufacturers with an MDR or IVDR file in front of a Notified Body: CER literature route, appraisal, equivalence, PMCF and performance-study statistics. Second, RA consultancies and CROs that want to deliver those sections under their own brand; I do that work as a subcontractor. Third, SaMD and medical-AI companies facing their first submission without an in-house biostatistics / clinical-evidence expert. What they share is the absence of an in-house methodologist and a dated gate on the file.
We are an RA consultancy or a CRO; how do you work as a subcontractor?
The file and the client relationship stay with you. I deliver the literature and statistical core at a fixed scope and fixed fee, under NDA, to your template and under your brand; the output is a section ready for your named clinical evaluator's signature. Whether I appear as the named methodological assessor is your choice. I also act as second assessor in screening and appraisal steps that require dual assessment, and as named biostatistician on device studies. Two rounds of revision are standard; responding to a Notified Body objection on the delivered section is within scope. Serial files run under a framework agreement with fixed turnaround times.
Do you also work on devices without artificial intelligence?
Yes. The CER literature route, appraisal, equivalence, PMCF sample size and IVDR performance statistics are independent of the device technology; I work on dental, cardiovascular, wound-care, IVD and electromedical files. The one exception is the therapeutic areas where I develop my own products.
You are not a physician; can you carry out this work?
Yes. My role is the named methodologist/biostatistician who designs and runs the study's statistical-validation evidence; I am not the principal investigator, coordinator, or consent-taker of the clinical study (those roles require a physician). My signature covers the statistical-methodological core and, when the dossier requires it, is presented together with your named clinical evaluator/physician. MEDDEV 2.7/1 Rev 4 defines the named clinical evaluator through relevant higher education and demonstrated experience. I have built and peer-reviewed a medical-AI device; I construct validation evidence through the eyes of both an engineer and a methodologist.
Do you set up ISO 13485 / a quality management system (QMS)?
No. ISO 13485 / QMS setup, auditing, and certification are outside my scope; I refer this work to suitable firms. My quality domain is not the factory but the methodological quality of the evidence and the model: ML-validation rigor, data / ground-truth / bias, reproducibility, and statistical integrity.
How does pricing work?
The model is one of three: a fixed-scope package (CER literature core, PMCF or IVDR statistics, validation design; deliverable and timeline written up front), a day rate (as named biostatistician for CROs and RA consultancies), or a monthly retainer. I do not work hourly. For RA consultancies and CROs, serial files run under a framework agreement at wholesale rates. Numbers are given in a written offer after the free scoping call; a price given before the scope is seen is either too low or too high.
Is there a conflict of interest if there is an area where you develop your own product?
In the therapeutic areas where I develop my own product, I do not provide consulting, to avoid a conflict of interest. In all other SaMD / AI-health areas I work, and every engagement runs under confidentiality (NDA).