Ongoing QA/RA support for medical software teams
I work as your part-time quality and regulatory lead at any stage of the life cycle: while you design and develop the software, through verification and validation, and after launch, when releases, post-market surveillance and surveillance audits have to keep running. You pay for the hours used, without a full-time hire.
- Price
- €50/hour, time and materials
- Format
- Regular or as-needed hours, inside your team’s tools
- For
- Any stage: development, V&V, on the market
- Markets
- EU · UK · Singapore · Malaysia
Who this is for
- Teams in development that need QA/RA input on design controls, verification and validation without a full engagement
- SaMD companies with CE marking or other approvals and no in-house QA/RA lead
- Teams whose regulatory lead has left and who need continuity before hiring
- Small companies where a full-time QA/RA role is not yet justified
- Teams that release often and need each change assessed quickly
Before and after launch
During development, the work is design and development (D&D) and verification and validation (V&V): design inputs and reviews, test plans and reports, traceability, and a risk file kept current as the product changes.
After certification, EU MDR requires the manufacturer to keep its QMS, technical documentation and post-market surveillance up to date. For Class IIa devices a periodic safety update report (PSUR) is due at least every two years; for Class IIb and III, at least every year. Serious incidents must be reported within the legal deadlines, and the Notified Body returns for surveillance audits. Every software release also needs a documented decision on whether it is a change the Notified Body must hear about.
Post-market surveillance for SaMD · Production support under EU MDR
What’s included
We choose from this list and fix it in the proposal, with the hours that match your stage, release cadence and obligations. Work is charged at €50 per hour on a time-and-materials basis, across the full life cycle.
Development, changes and releases
Design and development (D&D) and verification and validation (V&V) support, change impact assessment before releases, updates to risk management and technical documentation, and a decision on whether the Notified Body must be informed.
Post-market surveillance
Review of complaints, feedback and other PMS data, trend analysis, PSUR or PMS report, and PMCF activities where planned.
Vigilance support
Help assessing whether an event is reportable and preparing the report and any field safety corrective action. The manufacturer submits.
CAPA and internal audits
Root cause analysis, CAPA follow-up, internal audits on the agreed schedule and management review preparation.
Surveillance audits
Preparation for Notified Body or certification body surveillance audits, support on the day and responses to findings.
Regulatory updates and training
What new MDCG guidance, standard revisions, EUDAMED and the AI Act mean for you, and training for new team members.
Who does what
| Activity | Your team | Me |
|---|---|---|
| Release decisions | Approves the release | Assesses regulatory impact, updates records |
| Complaints and PMS data | Collects and logs | Analyses, drafts PSUR or report |
| Vigilance reporting | Decides and submits as manufacturer | Assesses, drafts |
| CAPA | Owns actions | Facilitates, checks effectiveness |
| Regulatory roles (PRRC, EU authorised representative) | Appoints | Not included |
How it starts
Free call
Your device, its stage, markets, release cadence and open obligations.
Health check
A short review of the QMS and records to see what is overdue and what is routine.
Proposal
The tasks covered, the expected hours, how we communicate, and how extra work around audits or submissions is handled. Hours are charged at €50 per hour.
Not included
- Acting as PRRC under Article 15, as EU authorised representative, UK responsible person, or local registrant in Asia
- Notified Body, certification body and regulator fees
- Writing software or running tests
- Out-of-hours on-call cover, unless agreed separately
Price: €50 per hour, on a time-and-materials basis. The number of hours each month depends on device class, release frequency, number of products and markets, and the state of your QMS. Fees are in EUR, excluding applicable taxes.
Questions about ongoing support
You get an experienced lead for the hours your obligations require, without recruiting for a role that may not need full-time attention yet. When you hire, I can help with the hand-over.
No. The same time-and-materials support covers design and development, verification and validation and preparation for certification, as well as the period after launch. You pay €50 per hour for the hours used.
Not as part of this service. Article 15 of the MDR requires the manufacturer to have a person responsible for regulatory compliance; micro and small enterprises may use an external person who is permanently and continuously at their disposal. We can discuss your options in the call.
Yes, for post-market and change obligations in the UK, Singapore and Malaysia alongside the EU, within the agreed scope. Local roles such as a UK responsible person or a registrant in Asia stay with your appointed partners.
Additional hours for audits, submissions or incidents are charged at the same rate of €50 per hour. The proposal sets out how they are agreed, so you know the cost before extra work starts.
QA/RA support when you need it
Tell me about your stage, releases and obligations in a free 30-minute call.