Medical Device
Supplier Audit Services
Qualify and monitor critical suppliers with audits built around device risk, outsourced processes, and the evidence your quality system needs. Pure Global conducts independent second-party audits and follows findings through corrective action without presenting the work as certification.
Risk-Based
Supplier Oversight
A certificate and questionnaire do not show whether a supplier can consistently control the process that matters to your device. We rank suppliers by product, patient, process, regulatory, and continuity risk; define audit criteria from the approved scope and quality agreement; examine objective evidence; and connect findings to qualification, purchasing controls, change management, and CAPA. The service is a second-party supplier audit, not a certification or MDSAP audit.
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.
Audit What Matters
to the Device
Audit depth should reflect what the supplier controls and how failure could affect safety, performance, sterility, software, data integrity, conformity, or supply continuity. We establish a product- and process-specific plan before the audit and choose on-site, remote, or hybrid methods based on the evidence that must be observed.
Risk and scope definition
Review the supplied product or service, specifications, process criticality, prior performance, quality agreement, regulatory exposure, changes, and open quality signals.
Evidence-based audit
Interview process owners, sample records, trace material and decisions, observe operations where needed, and test whether written controls are implemented and effective.
Device-specific criteria
Assess applicable QMS, technical, software, laboratory, sterilization, cleanroom, calibration, traceability, data-integrity, and change-notification controls without using a generic checklist alone.
Turn Audit Evidence
into Better Control
The report is useful only when it supports a documented supplier decision and durable correction. We distinguish critical risk from documentation weakness, explain the evidence behind each finding, review the supplier's response, and follow actions to verification. Results feed the manufacturer's approved supplier record and ongoing monitoring plan.
Clear, risk-ranked reporting
Document scope, criteria, samples, observations, findings, supporting evidence, risk significance, positive practices, and unresolved limitations in a decision-ready report.
CAPA response review
Evaluate containment, root cause, correction, corrective action, ownership, timing, evidence, and proposed effectiveness checks rather than accepting a closure date alone.
Ongoing supplier monitoring
Translate audit results into approval status, conditions, incoming controls, quality metrics, change-notification expectations, re-audit triggers, and escalation criteria.
Audit Support across the Supplier Lifecycle
Choose a focused audit for one decision or coordinate a risk-based program across sites and regions.
Qualification Audits
Assess a prospective supplier's capability and controls before approval, transfer, scale-up, or a critical outsourcing decision.
Surveillance Audits
Reassess critical suppliers based on time, risk, performance, process change, regulatory change, or the monitoring plan.
For-Cause Audits
Investigate serious defects, complaints, recalls, recurring nonconformity, data concerns, unauthorized change, or supply disruption.
CAPA Follow-Up
Review responses, verify implementation and effectiveness, resolve evidence gaps, and support the final supplier disposition.
Medical Device Supplier Audit FAQs
A medical device supplier audit is a systematic, evidence-based assessment of a supplier's ability to meet defined quality, technical, regulatory, and contractual requirements for the product or service it provides. The audit may support initial qualification, periodic surveillance, a significant change, or investigation of a quality event. It should examine the controls that matter to the device and outsourced process, not merely confirm that the supplier owns a certificate.
No. Pure Global's supplier audit is a second-party audit conducted for the manufacturer or another customer in the supply chain. It can use ISO 13485, FDA QMSR, a quality agreement, technical specifications, and other applicable criteria, but it does not issue ISO certification. It also does not replace an MDSAP audit performed by a recognized Auditing Organization. The report supports the manufacturer's supplier-control decision.
Audit priority should follow risk rather than spend alone. Candidates often include contract manufacturers, critical component and material suppliers, contract sterilizers, test laboratories, software or cloud providers, calibration services, packaging suppliers, and other outsourced processes whose failure could affect safety, performance, regulatory compliance, data integrity, sterility, traceability, or supply continuity. Supplier history, complaints, changes, nonconformities, and available third-party evidence can raise or lower the needed audit depth.
A remote or hybrid audit can be effective when records, interviews, system demonstrations, and selected evidence answer the audit objectives. It is less suitable when the decision depends on observing physical process controls, segregation, environmental conditions, traceability, equipment, laboratory practice, sterilization, data infrastructure, or an unresolved on-site quality concern. We document the method and any access limitations, then recommend an on-site phase when remote evidence is insufficient.
A useful report identifies the supplier site, audit dates, team, scope, criteria, product or process, methods, people interviewed, records and operations sampled, findings, supporting evidence, risk significance, positive practices, unresolved limitations, and the conclusion relevant to supplier approval. It should distinguish observed facts from interpretation and give the manufacturer enough information to define conditions, controls, CAPA expectations, and follow-up.
The supplier should respond with timely containment where needed, a proportionate investigation, root cause, correction, corrective action, owners, dates, and objective evidence. The manufacturer then evaluates whether the response addresses the systemic issue and whether an effectiveness check or re-audit is necessary. Pure Global can review that package, request missing evidence, verify selected actions, and document the status, but the manufacturer retains responsibility for the supplier approval and risk decision.
One Audit Program,
Global Supplier Visibility
Apply consistent risk and evidence principles across supplier sites while adapting criteria to the process, device, market, and quality agreement.
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