Senior Quality leadership support,
without adding a full-time executive.
External senior Quality support on a defined retainer: management review preparation, audit and inspection readiness, QMS prioritization, supplier oversight, and executive advisory support.
Ongoing external advisory and implementation support, typically two to four days a month, within a clearly defined consulting scope.
Temporary senior-level support during a leadership vacancy, focused on continuity, priorities, and transition support without becoming an employee or assuming an internal executive appointment.
Defined-scope guidance for founders, general managers, and investors who need an experienced Quality perspective, not an employee placement.
Most quality failures start as leadership gaps, not paperwork gaps.
A manufacturer with fifteen to two hundred employees usually has capable quality engineers and a quality manager whose week is already full of release, complaints, and supplier issues. What is missing is the person who owns the system as a whole: who decides which findings are systemic, whether a corrective action actually worked, and what management is told about the state of the system.
Those responsibilities are written into the standards, and they do not scale down with headcount. A company with forty employees is held to the same requirements as a company with four thousand. What can scale down is how much of a director's week you buy.
Rule: ISO 13485:2016 Clause 5.5.2 (management representative) and Clause 5.6 (management review). Since 2 February 2026, 21 CFR 820.10 brings ISO 13485:2016 into the FDA QMSR by reference, so these are US inspection expectations as well as certification requirements.
What the engagement actually owns.
- Management review. Preparing and chairing it against the full input list in Clause 5.6.2, and turning the outputs into assigned, dated actions rather than a slide deck.
- Internal audit programme. Setting the programme required by Clause 8.2.4 on process status and importance, reading findings for systemic significance, and keeping auditors independent of the work they audit.
- CAPA governance. Chairing the review board, holding a defensible line between a correction and a corrective action, and closing effectiveness checks on evidence rather than on task completion.
- Supplier controls. Approval criteria, re-evaluation, and audit scheduling under Clause 7.4, including the purchasing and verification records inspectors sample first.
- Design control oversight. Phase gate discipline under Clause 7.3, design transfer, and a design history file that survives both technical documentation or conformity-assessment review and an FDA inspection.
- Post-market and complaints. Complaint file requirements retained in 21 CFR 820.35, vigilance decisions, and the feedback loop back into risk management under ISO 14971:2019.
- EU MDR PRRC support. External PRRC arrangements for eligible micro and small enterprises where Article 15 qualifications and availability requirements are satisfied, or support for an internally appointed PRRC.
- Board and investor reporting. A quality position that survives diligence, stated in terms of regulatory exposure rather than closure percentages.
Four situations where this works.
- The Quality leadership seat is empty. Transitional senior support while you recruit, with responsibilities and escalation routes defined in writing. The organization retains its required internal management representative appointment.
- You are building the system. A first ISO 13485 certification or an MDSAP application, where the order of decisions matters more than the volume of documents.
- You are remediating. A warning letter, a Form 483, a certification-body major nonconformity, or a certificate under suspension, where responses are already committed and now have to be delivered.
- You are buying or being bought. Quality due diligence, and the twelve months after close when two systems have to become one.
Four phases, in this order.
The order matters. Assessment before planning, planning before execution, and nothing committed to a regulator or certification body until the underlying work has an evidence-based and achievable date attached to it.
Assessment
Two to three weeks of document review and process walkthrough. You get a written position on where the system is exposed, ranked by regulatory exposure, product risk, and business impact.
Plan and appointment
Scope, responsibilities, and reporting line agreed in writing, including how the engagement supports the internally appointed management representative and which decisions remain with top management.
Execution
A standing cadence of management review, CAPA board, audit oversight, and supplier decisions, with on-site days booked around audits and inspections.
Transition
Handover to a permanent hire or an internal successor, with a documented turnover file. Every engagement is built to end.
Three things owners ask before they sign.
These usually come from the owner or the general manager rather than from the Quality team. Each answer is tied to the applicable requirement so internal counsel, regulatory advisers, and certification partners can review the basis.
Does Fractional QA Leadership include acting as the PRRC?
No. This service does not include appointment as the EU MDR Person Responsible for Regulatory Compliance. The manufacturer must separately appoint an appropriately qualified PRRC who meets the applicable Article 15 requirements.
SAQMS may support QMS coordination, documentation readiness, and communication with the appointed PRRC, but does not present Fractional QA Leadership as a PRRC appointment and does not assume the manufacturer’s legal or regulatory responsibilities.
Rule: EU MDR Article 15(1) and 15(3); Commission Recommendation 2003/361/EC; MDCG 2019-7.
We never audit our own work
If SAQMS develops or remediates a process, that work is not subsequently audited by the same consultant. Audit independence is maintained through a separately assigned qualified professional or the client’s trained internal auditors. The arrangement is defined in the scope before work begins.
Rule: ISO 13485:2016 Clause 8.2.4, and the impartiality requirements in ISO/IEC 17021-1 Clause 5.2.
You stay the manufacturer
Bringing in outside leadership does not transfer legal responsibility for the devices or the Quality Management System. That remains with the manufacturer. The engagement provides senior judgement informed by extensive manufacturer-side, Quality-leadership, and lead-auditor experience. Responsibilities, decision limits, and escalation requirements are documented in the agreement.
Rule: 21 CFR Part 820 as amended by the QMSR, and EU MDR Article 10.
A retainer, not a payroll line.
Set by the agreed cadence, scope, risk profile, and onsite requirements. The engagement supports rather than replaces the organization’s required management representative appointment.
Shorter if you only need cover while you recruit. Longer if a certification or a clean-up programme is running.
A standing remote schedule, with on-site days booked around audits, inspections, and management review.
Set against a full-time hire, there is no recruitment fee, no benefits or payroll load, no equipment or relocation, and no severance exposure. You can add days during an audit or a remediation push and take them back off afterwards, and the notice to change or end the engagement is agreed in writing before it starts.
Work is delivered by qualified, experienced medical-device Quality consultants and professionals with lead-auditor experience. The proposed team, responsibilities, and independence controls are identified before the engagement is signed.
Before the first call.
How is this different from hiring a consultant for a project?
A project consultant delivers a defined piece of work and leaves. A fractional Quality consultant provides ongoing strategic guidance within a documented scope, participates in agreed meetings, and supports management decision-making between projects. The retainer provides continuity and experienced judgment without creating an employment relationship.
Does this service include acting as the EU MDR PRRC?
No. Fractional QA Leadership does not include appointment as the EU MDR Person Responsible for Regulatory Compliance. Where a PRRC is required, the manufacturer must separately appoint an appropriately qualified person who meets Article 15 requirements. SAQMS may support coordination and QMS alignment around the appointed PRRC, but does not present this service as a PRRC appointment.
Can the role be named as our management representative?
No. ISO 13485:2016 Clause 5.5.2 requires top management to appoint a member of the organization’s management. A fractional Quality leader can support, coach, assess, and strengthen that person’s work, but the external engagement does not replace the required internal appointment.
What happens during an FDA inspection or a certification-body audit?
On-site or remote support is defined in advance for planned audits and inspections. The engagement can coordinate readiness, document flow, management interviews, daily issue review, and response drafting. Under QMSR, FDA applies the incorporated ISO 13485:2016 requirements through 21 CFR Part 820, while notified body and MDSAP audits follow their applicable conformity-assessment criteria.
Will you take on a company already under a warning letter or a suspended certificate?
Potentially, following an initial conflict, capability, and scope review. These engagements require a dedicated remediation structure based on commitments already made to the agency or certification body, the feasibility of existing deadlines, available resources, and the level of executive support.
What does the first month look like?
Document review and process walkthrough, a written assessment ranked by regulatory exposure, and an agreed scope of responsibility. Nothing goes to your board or to a regulator in the first month that has not been verified against records.
Related reading: medical device QMS remediation services, risk management services, and the full range of quality and regulatory solutions.
