QA Support for Medical Device & IVD Manufacturers

Our QA Support service gives medical device and IVD manufacturers day-to-day quality assurance capacity: internal and supplier audits, CAPA remediation, complaint handling, post-market surveillance execution, and QMS gap closure. Qserve consultants embed alongside an existing quality team rather than working at arm's length, so support scales up or down as audit season, growth, or staffing gaps demand.

A certified quality management system is not optional overhead for a medical device or IVD manufacturer — it's the mechanism that keeps products on the market. Since February 2, 2026, the FDA's Quality Management System Regulation (QMSR) has replaced the prior 21 CFR Part 820 framework, aligning US requirements with ISO 13485 and adding documentation expectations many manufacturers haven't fully absorbed yet. Add ongoing EU MDR and IVDR obligations, Notified Body audits, and MDSAP surveillance, and a lean QA team ends up carrying more compliance surface than its headcount can cover. Backlogs build in CAPA, supplier audits slip, and findings from an external audit arrive faster than a stretched team can close them.

Qserve works differently from a generic staffing firm or a one-off audit shop. Quality assurance for medical devices and IVDs sits at the center of Qserve's regulatory practice, so QA Support consultants carry the same EU MDR/IVDR, US FDA, and ISO 13485 depth used across Qserve's regulatory affairs and clinical work — not a QA specialist parachuted in without context on the rest of the file. Engagements run from a single mock audit to embedded, multi-year QA/RA staffing, and clients range from first-time manufacturers building a QMS from scratch to established companies remediating findings ahead of a recertification audit.

When do you need QA support?

Manufacturers typically bring in QA Support at a handful of predictable pressure points:

• Preparing for a Notified Body audit, FDA inspection, or MDSAP surveillance visit
• Working through a CAPA or supplier-quality backlog that has outgrown current headcount
• Adjusting a US quality system to the FDA's QMSR requirements
• Losing QA or RA staff during a transition, leave, or rapid hiring gap
• Scaling a QMS after a funding round, acquisition, or market expansion
• Rebuilding a QMS from scratch ahead of a first submission

The FDA's Quality Management System Regulation (QMSR) took effect February 2, 2026, replacing the prior 21 CFR Part 820 framework and incorporating ISO 13485:2016 by reference. Qserve helps US and export manufacturers map existing 21 CFR Part 820 procedures to the QMSR/ISO 13485 clause structure, close documentation gaps, and prepare for the FDA's updated inspection approach, so the shift doesn't stall an ongoing audit or submission.

What MDSAP audit support does Qserve provide?

The Medical Device Single Audit Program lets a single audit satisfy quality system requirements across the US, Canada, Brazil, Australia, and Japan. Qserve prepares manufacturers for MDSAP audits and mock assessments, reviews nonconformity grading ahead of an official visit, and supports remediation of findings, so one audit cycle covers multiple markets instead of five separate ones.