Build a QMS that works for your device, not against it.
ISO 13485:2016 is the foundation of every regulated market's quality system requirements. We design, document, and implement QMS structures that satisfy regulatory auditors and actually function as a management system — not just a documentation exercise.
ISO 13485:2016 applies across the entire product lifecycle from design and development through production, installation, and servicing. The standard's requirements extend to software development (IEC 62304), risk management (ISO 14971), and usability (IEC 62366-1). Most companies undergoing their first 13485 implementation significantly underestimate the scope of documented procedures required and the management commitment the standard demands.
We begin every QMS engagement with a structured gap analysis against all clauses of ISO 13485:2016, assessed against your current quality practices, documented procedures, and records. The gap analysis output is a prioritised action plan, not just a list of gaps. We identify which gaps affect regulatory submissions or market access on the shortest timeline and sequence the work accordingly.
QMS design must be proportionate to the complexity and risk of your device. A startup developing a single Class IIa device needs a leaner QMS than a contract manufacturer producing across multiple product lines and sites. We design the procedure set and document hierarchy to match your actual operation, not a generic textbook template.
Clause-by-clause assessment of current state versus standard requirements, with a prioritised remediation action plan and estimated effort.
Defined procedure map, document hierarchy, record types, and process interaction diagram designed for your specific product type, size, and regulatory scope.
Document showing how your QMS satisfies the quality system requirements of each target regulatory market (EU MDR Annex IX, 21 CFR Part 820, MDR 2017 Schedule II).
ISO 13485:2016 requires documented procedures for a defined set of processes — including control of documents (Clause 4.2.4), control of records (4.2.5), management review (5.6), competence and training (6.2), infrastructure and work environment (6.3, 6.4), risk management (7.1), design and development (7.3), purchasing (7.4), production (7.5), monitoring and measurement (8.2), and corrective and preventive action (8.5). The standard also requires many of these procedures to reference work instructions and maintain specific records.
We write procedures that are accurate to your actual processes, not copy-paste templates that describe a company different from yours. Each procedure is verified against the process it describes by walking through the process with your team. Records are designed to be completable by the people who do the work, not the people who wrote the procedure.
Full set of Level-2 procedures for all ISO 13485 mandatory documented procedures, written to your specific processes and regulatory scope.
Level-3 work instructions and record forms for key controlled processes — incoming inspection, production, labelling, sterilisation where applicable.
Top-level quality system description covering scope, exclusions, process interactions, and applicable regulatory requirements.
Document numbering scheme, revision control procedure, and (where needed) configuration in your existing DMS or a recommended cloud-based quality system.
Certification to ISO 13485:2016 by an accredited certification body requires a Stage 1 (documentation) audit and a Stage 2 (implementation) audit. Regulatory audits — from CDSCO, a notified body, or FDA — are unannounced or short-notice and focus on objective evidence that the system works, not just that the documents exist.
We conduct a formal pre-audit readiness assessment using the same clause-by-clause structure as a certification audit. We identify any remaining gaps in documentation or implementation, verify that records are complete and retrievable, and brief your team on audit conduct — how to answer auditor questions, what constitutes objective evidence, and how to handle minor findings under audit.
Internal audit simulating a Stage 2 certification audit, with a formal findings report and closing meeting that prepares your team for the real thing.
Practical guide for your team covering auditor interaction, objective evidence identification, and managing findings during audit.
Writing and verification of corrective action plans for audit findings, ensuring root cause is addressed and evidence of effectiveness is documented.
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Tell us where you are in the QMS journey — first implementation, remediation after a poor audit, or scaling to a new market. We will scope the engagement precisely.
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