Medical Device QMS
& ISO 13485 Consulting
Build a medical device quality management system that people can operate and regulators can inspect. Pure Global supports ISO 13485 implementation, FDA QMSR alignment, remediation, audit readiness, and quality-system scaling across product and market lifecycles.
One QMS,
Market-Ready
Quality-system work should connect product development, suppliers, manufacturing, complaints, post-market surveillance, and regulatory submissions rather than produce a shelf of generic procedures. We establish the applicable regulatory baseline, map existing processes and evidence, prioritize risk, and implement a controlled system sized to the organization. Consulting and readiness support remain separate from independent certification or MDSAP auditing.
Global Market
Research
We assist you with identifying which markets to expand to leveraging existing registrations and approvals.
Classification
And Grouping
Our local regulatory experts provide strategic support to determine classification of your product portfolio and the number of registrations that are required.
Market access
requirements
Based on the classification of your products, we can outline the required steps and information to obtain your registration.
Build Processes
That Work
We translate ISO 13485, FDA QMSR, and market-specific obligations into operating processes, records, ownership, and controls. The work begins with the organization's actual devices, risks, outsourced activities, software, facilities, and growth stage so the resulting system supports compliance without unnecessary bureaucracy.
Gap assessment and roadmap
Compare current procedures and records with the applicable QMS baseline, identify product and process risk, and sequence remediation around regulatory and commercial deadlines.
Process and document architecture
Define the quality manual, policies, procedures, work instructions, forms, records, roles, interfaces, and document controls needed to run a traceable system.
Implementation and evidence
Train process owners, execute workflows, create objective evidence, monitor effectiveness, and close practical gaps across design, supplier, production, and post-market activities.
Test the System
Before the Auditor Does
Readiness is demonstrated through records and consistent answers, not a last-minute document review. We test process interactions, trace samples through the system, review unresolved quality signals, interview process owners, and help teams correct weaknesses before an FDA inspection, certification audit, customer audit, or MDSAP assessment.
Internal audits and mock inspections
Develop a risk-based audit program, conduct process audits using auditors independent of the work being audited, simulate regulator or certification-body sampling, and document findings without disguising consultancy as certification.
CAPA and systemic remediation
Strengthen containment, investigation, root-cause analysis, correction, corrective action, effectiveness checks, trend review, and management visibility.
Management and team readiness
Prepare leaders and process owners to explain controls, produce records, understand quality objectives, and sustain the system after the audit closes.
From First Procedure to Continuous Improvement
Use a focused workstream for one quality problem or coordinate an end-to-end QMS implementation and readiness program.
ISO 13485 Implementation
Gap analysis, process design, documentation, training, evidence creation, internal audit, management review, and certification readiness.
FDA QMSR Alignment
Comparative analysis and U.S.-specific implementation support for the QMSR framework effective February 2, 2026.
MDSAP Readiness
Process and evidence preparation for the MDSAP audit model, without claiming to perform the regulatory audit or issue certification.
Lifecycle Quality
CAPA, complaints, supplier controls, change management, post-market processes, internal audits, metrics, and continuous improvement.
Medical Device QMS Consulting FAQs
A medical device QMS is the connected set of responsibilities, processes, controls, and records used to design, manufacture, release, monitor, and improve devices consistently. It covers more than document control: leadership, competence, risk, design and development, suppliers, production, identification and traceability, complaints, post-market feedback, nonconformity, CAPA, change, audits, and management review all interact. ISO 13485 is the internationally recognized medical device QMS standard used as a core regulatory baseline in many markets.
FDA's Quality Management System Regulation became effective on February 2, 2026 and incorporates ISO 13485:2016 by reference, along with specified terminology and U.S. supplemental provisions. This creates substantial alignment but not automatic equivalence: manufacturers must still identify applicable U.S. requirements and FDA authorities. We map one operating QMS to both baselines and document the additions rather than maintaining disconnected systems.
No. Pure Global provides consulting, implementation, remediation, internal-audit, and readiness support. ISO 13485 certification is issued by an external certification body; the applicable regulator, customer, or certification scheme may require that body to hold appropriate accreditation or designation. Keeping those roles separate protects impartiality. We can help select an appropriate certification body, prepare the QMS and evidence, support the audit response process, and close findings, but we do not represent our consulting review as certification.
A project can include a baseline and scope assessment, gap analysis, implementation roadmap, quality manual, procedure and record architecture, design and development controls, risk integration, supplier controls, production and service processes, software lifecycle interfaces, complaints, vigilance, CAPA, change control, internal audits, management review, metrics, training, certification readiness, and inspection preparation. We agree the boundaries and deliverables before work begins so the project fits the organization's products and regulatory targets.
Yes, as a readiness and remediation service. FDA explains that MDSAP allows a recognized Auditing Organization to conduct one regulatory audit that addresses participating authorities' requirements. Pure Global is not presented as that Auditing Organization. We can map processes to the audit approach, review evidence, conduct internal or mock audits, train process owners, and support corrective actions before the independent MDSAP audit.
The timeline depends on product maturity, headcount, outsourced processes, existing controls, record history, software and manufacturing complexity, and the date of the planned audit or submission. A focused remediation can be shorter than a first-time implementation, while a new organization needs enough operating time to generate records, complete internal audits and management review, and close findings. We define a phased plan after the gap assessment rather than promising certification by a fixed date.
One Quality System,
Global Evidence
Build a common ISO 13485 foundation, then map the additional quality-system and regulatory evidence required by each target market.
Let's Talk,
Anywhere You Are.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
Contact us