IVDR Phase 2

Quality Planning

Quality Planning

Quality Planning Procedure

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IVDR Transition, QP

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QMS IVDR Transition, QP

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Basic Data

Basic Data

Device Classification

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UDI-DI Implementation

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Basic UDI-DI

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Interchangeability

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IVDR QMS Alignment

IVDR QMS Alignment

(a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system;

Article 10 (8)(a) Change Management

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(h) verification of the UDI assignments made in accordance with Article 24(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 26;

Article 10 (8)(h) Product Identification

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(g) product realisation, including planning, design, development, production and service provision;

Article 10 (8)(g) Product Realization

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(b) identification of applicable general safety and performance requirements and exploration of options to address those requirements;

Article 10 (8)(b) Regulatory and Standards Watch

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(d) resource management, including selection and control of suppliers and sub-contractors;

Article 10 (8)(d) Resource Management

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(l) management of corrective and preventive actions and verification of their effectiveness;
(m) processes for monitoring and measurement of output, data analysis and product improvement.

Article 10 (8)(l/m) Data Analysis

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(c) responsibility of the management;

Article 10 (8)(c) Management Controls

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Validation System

Validation System

Equipment and Production Process Controls

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Preventative Maintenance

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Process Validation

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Statistical Techniques

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Sterilization

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Equipment Qualification

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Production Software Validation

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Material Qualification

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Test Method Validation

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Packaging Validation

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Sterilization Validation

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Equipment Requirements

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Excel / PLC /System Software Validation

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Biocompatibility Requirements

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Aging / Testing Requirements

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Master Validation Plan

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Test Protocols and Reports

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