01
Specialist service
Internal Audits & MDSAP Readiness
Internal audits for ISO 13485, MDSAP, ISO 9001, ISO 14001 and ISO 45001, with scope based on risk.
Explore serviceMedical device quality · MDSAP · Management systems
Regulatory insight.
Operational
confidence.
Measurable improvement.
Independent internal audits, critical supplier audits, FDA Form 483 and Health Canada remediation, practical QMS training and remote QMS implementation.
Independent expertise.
Practical support backed by evidence.
Practical support backed by evidence.
Quality. Regulatory. Compliance.Expertise in every detail.
600+
Historical audit
engagements
Explore our expertise
Internal Audits & MDSAP Readiness
Internal audits for ISO 13485, MDSAP, ISO 9001, ISO 14001 and ISO 45001, with scope based on risk.
Explore this serviceSelect your area of focus
Technical depth.International perspective.
20+Years of management
system leadership
system leadership
01 / Specialist experience
Practical experience
where compliance
meets manufacturing.
Our experience includes more than 600 second and third party audits and over two decades of quality management leadership. We select auditors and consultants with the technical experience each assignment needs.
We support medical device manufacturers, contract manufacturers, electronics, metal fabrication, packaging and other regulated businesses and operations where product quality is critical. Auditor and consultant selection is based on the needs of the assignment.
MDSAP medical device audit experience Remote, efficient implementation model
Explore our approach 02 / What we do
Focused services.
One practical approach.
Work directly with experienced auditors and consultants, with clear scopes, useful reports and practical next steps.
02
Specialist service
Global Critical Supplier Audits
Independent supplier qualification audits, surveillance and follow up, with scope based on risk.
Explore service03
Specialist service
FDA 483 & Nonconformity Remediation
Practical support for FDA Form 483 observations, Health Canada inspection findings and major/minor audit nonconformities.
Explore service04
Specialist service
Customized QMS Training
Practical training using your own QMS procedures, real examples and coached case studies.
Explore service05
Specialist service
Remote QMS Consulting
Build and implement an ISO 13485, FDA QMSR or integrated management system that fits your operations.
Explore service
FDA QMSR · Effective February 2, 2026
ISO 13485 alignment
is not the same
as a certificate.
The FDA Quality Management System Regulation incorporates ISO 13485:2016 by reference for applicable device manufacturers, alongside additional FDA requirements. FDA does not require an ISO 13485 certificate. Our QMSR implementation support focuses on the processes, records and evidence needed for inspection readiness.
Explore QMSR implementationFrom requirements to readiness
Evidence over
assumptions.
Applicable processes
Implementation evidence
Inspection readiness
Built for organizations of different sizes
We adapt the approach to your product risk, operations, regulatory markets and available resources, from small medical device businesses to manufacturers with multiple sites.
03 / Signature offerings
Designed around
your operation.
Training and implementation that fit your operation.
01 / Practical trainingTraining with your actual QMS
Teams practice on approved procedures and anonymized complaints, nonconformities and supplier problems. Exercises require participants to apply, not simply recall, the material.
Practical training
02 / Remote consultingRemote implementation
Structured workshops, controlled document reviews and implementation coaching can avoid unnecessary travel without compromising evidence or oversight.
Remote consulting04 / Client perspectives
A closer look at
working together.
Perspectives on audit support, quality training and the practical work of improving a management system.