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Internal audits are a critical pillar of every medical device Quality Management System — and a mandatory requirement under ISO 13485:2016 (Clause 8.2.4), MDSAP, and FDA QMSR (21 CFR Part 820). Poorly planned or inadequately documented audits are among the most common findings during third-party assessments and regulatory inspections. This Audit Management SOP package gives…
The CAPA SOP package includes:
The Change Control SOP package includes:
The Complaint SOP package includes:
The customer related processes SOP ISO 13485 addresses a requirement that is often underestimated in its regulatory significance. Customer related processes — governed by ISO 13485:2016 Clause 7.2 and assessed as a dedicated audit task under MDSAP — define how a medical device organization determines, reviews, and communicates product and service requirements with its customers….
The design control SOP ISO 13485 package addresses one of the most complex and most frequently cited areas of nonconformity in medical device quality management system audits. Design and development controls — required under ISO 13485:2016 (Clause 7.3), EU MDR 2017/745 (Annex II), and FDA QMSR (21 CFR Part 820) — govern the entire product…
The Document Control SOP package includes:
The Human Resources and Training SOP package includes:
The KPI & Data Analysis SOP package includes:
Management Review SOP – ISO 13485, MDSAP & FDA QMSR Management review is one of the most frequently cited findings in ISO 13485 audits and FDA inspections — yet it’s often mishandled due to poor documentation or inadequate procedure design. This Management Review SOP package gives your quality team an audit-ready framework to plan, conduct,…
The medical device file SOP EU MDR ISO 13485 addresses one of the most critical structural requirements of EU MDR 2017/745 conformity assessment. Every medical device placed on the EU market must be supported by a complete, current, and well-organized Medical Device File — the structured compilation of technical documentation required by EU MDR Annex…
The Non-Conformity Management SOP package includes:
The process validation SOP ISO 13485 package addresses one of the most technically demanding requirements in medical device manufacturing. Process validation — required under ISO 13485:2016 (Clause 7.5.6), MDSAP, and FDA QMSR (21 CFR Part 820) — applies to all manufacturing processes whose outputs cannot be fully verified by subsequent inspection or testing. Sterilization, welding,…
Risk Management SOP — ISO 14971, ISO 13485, MDSAP & FDA QMSR Compliant Risk management is a foundational requirement for medical device manufacturers — and one of the most scrutinized areas in ISO 13485 audits, MDSAP assessments, and FDA inspections. Without a structured, documented approach aligned with ISO 14971:2019, gaps in your risk management process…
The Computer System Validation package includes:
Unique Device Identification is a mandatory regulatory requirement for medical device manufacturers placing products on the EU market under EU MDR 2017/745 and on the US market under FDA QMSR (21 CFR Part 830). UDI assignment, labeling, and database registration obligations apply across all device classes — and failure to comply with UDI requirements is…