Quality. Regulatory. Compliance.

About
QMS Professionals.

Independent auditing, regulatory support and management system consulting.

Request a proposal Discover our approach

600+Historical second and
third party audits

Technical depth.
Independent perspective.

20+Years of management
system experience

Precision manufacturing.
Practical experience.

01 / Professional experience

Experienced quality and regulatory leadership

QMS Professionals draws on more than two decades of management system auditing, implementation, training and senior quality leadership experience across medical devices, electronics, contract manufacturing, fabricated metals, plastics and other industries.

Our experience includes senior professionals who have held senior quality and regulatory positions, including Director of Quality & Regulatory Affairs, and a documented track record of more than 600 second and third party audits involving ISO 13485, ISO 9001, environmental and occupational health and safety management systems, and historical CMDCAS and European medical device frameworks.

Medical devicesElectronicsContract manufacturingFabricated metalsPlastics

02 / Specialized experience

Specialized
medical device experience.

Experience includes MDSAP auditing, medical device QMS requirements, supplier controls, auditing based on risk, corrective actions and international manufacturing operations. Past credentials and engagements are described as professional experience, not as current certification body authorization or endorsement.

Explore audit & MDSAP support

Auditing based on risk Supplier controls Corrective actions Medical device QMS

03 / How we work

Independence
and confidentiality.

Each project is screened for impartiality and conflicts of interest. QMS Professionals’ consulting activities are separate from any accredited certification body services, and certification outcomes cannot be promised or influenced.

Impartiality &
conflict screening

Separate consulting
activities

No promised
certification outcomes

04 / Our expertise

Specialist support.
A practical next step.

Independent auditing, regulatory support and management system consulting.

Explore all expertise

Internal Audits & MDSAP Readiness Global Critical Supplier Audits FDA 483 & Nonconformity Remediation Customized QMS Training Remote QMS Consulting

05 / Client perspectives

A closer look at
working together.

Perspectives on audit support, quality training and the practical work of improving a management system.

An audit with a clear purpose.

The internal audit was planned around our processes and the evidence we needed to review. We came away with a clear picture of the gaps and a practical way to organize the next steps.

Internal Audits & MDSAP Readiness

A closer look at supplier risk.

The supplier review gave our team a structured view of the controls that mattered. The findings were easy to discuss with our supplier, and the follow up priorities were clear.

Global Critical Supplier Audits

Structure for corrective action.

A difficult set of findings felt more manageable once the evidence, responsibilities and action plan were brought together. The support kept our team focused on understanding the causes and documenting the work.

FDA 483 & Nonconformity Remediation

Training we could put to work.

Working through examples from our own procedures made the sessions useful. Our team had room to ask questions, practise the process and connect the training with the work they do each day.

Customized QMS Training

Remote support that kept us moving.

The workshops and document reviews gave us a steady rhythm for improving our quality system. We knew what to prepare, what needed a decision and what to work on before the next session.

Remote QMS Consulting

AboutQMS Professionals.

Experienced quality and regulatory leadership

Specializedmedical device experience.

Independenceand confidentiality.

Impartiality &conflict screening

Separate consultingactivities

No promisedcertification outcomes

Specialist support.A practical next step.

A closer look atworking together.