The question comes up in almost every first meeting with an SME manufacturer: “We can do this in-house, right?” Sometimes yes. Often no. Always with nuances that both camps — advocates of fully in-house and advocates of fully outsourced — tend to ignore.
What “doing it yourself” underestimates
The learning curve is long. A quality manager who is competent on ISO 13485 is not immediately operational on MDR clinical evaluation. Writing a CER that meets the expectations of a Class IIa notified body, with a systematic literature review documented in line with MEDDEV 2.7/1 rev 4 and the MDCG guidelines, has to be learned. Building up this expertise takes time — often 6 to 12 months of supervised practice before genuine autonomy.
The cost of internal time is real but invisible. A quality manager working full-time on an MDR project for 18 months represents a payroll cost of 60,000 to 90,000 euros, excluding employer contributions. This cost does not appear in the “MDR project” budget, but it exists. Comparing it to the cost of an external consultant over an equivalent scope often changes the perception.
Mistakes cost more than prevention. A file submitted to a notified body with major clinical gaps triggers a request for additional information, a suspension of the review period, and a restart with supplementary data. The associated delays often amount to several months and to costs higher than the cost of preventive support.
What “full outsourcing” underestimates
A consultant cannot do everything alone. Knowledge of the product, of the manufacturing processes, of the incident history and of customer feedback belongs to the internal team. A consultant who writes a file without access to this information produces a generic file. The work of making the information available and validating the content remains the manufacturer’s responsibility.
Dependence creates fragility. A QMS entirely written and maintained by an external provider, without internal ownership, collapses when the provider changes or when the notified body asks to interview the teams during an on-site audit.
The costs of poorly framed support can spiral. An open-ended mandate with a consultant, without defined milestones or deliverables, generates overruns. Effective support is support with clear objectives, precise deliverables and contractual deadlines.
The hybrid model: the most often relevant answer
In most mid-sized SMEs (10 to 50 people), the optimal solution is a hybrid model: internal resources trained and autonomous on ongoing activities (QMS, post-market surveillance, management of non-conformities), and specialised external support on highly technical one-off tasks (clinical evaluation, risk management for complex devices, preparation for the notified body audit).
This split combines internal knowledge of the product with external experience of regulatory expectations. It reduces dependence while maintaining quality.