QA Support
QA Support services help you build, maintain, and scale quality management systems
We provide hands-on experience to ensure compliance
As a medical device or IVD manufacturer, having a robust ISO 13485-certified Quality Management System (QMS) is essential for regulatory compliance and successful market access.
Maintaining a high-quality QMS in the MedTech industry is not just a regulatory requirement—it’s the foundation of your business. Keeping up with evolving global regulations while ensuring ongoing ISO 13485 compliance can be a complex task.
From managing internal and external audits, supplier quality control, and document management to scaling your QMS to support rapid growth—these challenges require expertise and strategic support.
Limited in-house resources, evolving regulatory expectations, and the pressure to bring products to market quickly can stretch QA teams thin.
Qserve can help you with these challenges. Whether you need:
- Day-to-day QA support to manage backlogs or provide temporary support
- Perform internal and supplier audits
- Perform Mock MDSAP audits or mock FDA inspections
- Audit preparation for Notified Body audits or FDA inspections
- Remediate findings from third party audits
- Implement a compliant QMS system from scratch
- Implement an electronic QMS tool (eQMS)
- Perform Gap assessments on your exisisting QMS and propose improvements
We support clients in overcoming these challenges with practical, tailored solutions. Our team integrates seamlessly to strengthen your quality management function. From startups to established manufacturers, we provide the hands-on expertise to ensure compliance, reduce risk, and foster a true culture of quality.
Satisfied Clients
Discover how we can help:
Quality planning
A quality plan for medical device companies is a series of documents which defines the standards for a process, product, or organization, and provides detail on how these quality standards are achieved.
QMS Gap Assessment and implementation
We help you establish, implement, and maintain robust QMS systems aligned with international standards and regulatory requirements.
Ad Hoc & Interim QA/RA support
If you need QA/RA expertise, our interim services provide the flexibility you need to succeed.
MDSAP Support
This program reduces the audit burden on companies by replacing multiple country-specific audits and inspections with one comprehensive audit.
PMS Support
We help you plan, execute, and document post-market surveillance activities that meet global regulatory expectations and drive product improvement.
Complaint Handling Support
From intake to investigation and reporting, we streamline complaint handling to ensure compliance, traceability, and timely response.
CAPA Support
We guide you in building effective, audit-ready CAPA processes that address root causes and prevent recurrence without overcomplicating your system.
MedTech companies can avoid costly gaps and rework by building right-sized, compliant quality systems from the start. Through proactive planning, lean documentation practices, and clear role alignment, MedTech consultancy firms can streamline QA operations that will reduce delays, audit findings, and resource strain while ensuring quality supports, rather than slows, your growth.
We provide flexible QA support tailored to your needs. Whether it's building or optimizing your QMS, preparing for audits, managing CAPAs, or training your team. Our experts integrate seamlessly with your operations to deliver practical, compliant solutions that reduce risk, improve efficiency, and scale with your business.
Couldn't find your question?
Why is a Quality Management System (QMS) important?
A robust QMS ensures compliance with international regulations like ISO 13485, FDA 21 CFR Part 820, and EU MDR/IVDR. It helps standardize processes, reduce risk, ensure product quality, and support continuous improvement throughout your device’s lifecycle.
What QA support services does Qserve offer?
Qserve provides a full range of QA services, including:
- Day-to-day QA support
- QMS gap assessments and implementation
- Audit preparation and support
- CAPA planning and remediation
- Complaint handling and PMS support
- MDSAP readiness
- Ad hoc or interim QA/RA staffing solutions
Does Qserve support regulatory standards like ISO 13485 and FDA 21 CFR Part 820?
Absolutely. Our QA experts are experienced with a wide range of standards and regulations, including ISO 13485, ISO 9001, ISO 27001, FDA 21 CFR Part 820, EU MDR/IVDR, and MDSAP-specific requirements. We help you apply these frameworks practically and efficiently.
How can I prepare for audits with Qserve’s help?
Qserve provides audit readiness assessments, mock audits, and hands-on support to ensure your QMS, documentation, and processes are fully prepared for regulatory and notified body inspections. We also assist with responding to and remediating findings.
What is CAPA support, and why is it critical?
Corrective and Preventive Action (CAPA) processes are essential for addressing nonconformities and preventing recurrence. Qserve helps you build streamlined, audit-ready CAPA systems that identify root causes and drive meaningful improvements without overburdening your organization.
Can Qserve provide interim QA resources if I have staffing gaps?
Yes. We offer flexible interim and ad hoc QA/RA support to help you maintain compliance and momentum during periods of transition, rapid growth, or resource constraints.