MDR Phase 2

Quality Planning

Quality Planning

Quality Planning Procedure (QP)

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QMS Transition Quality Plan (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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MDR QMS Alignment

MDR 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 (9)(a) Change Management

(h) verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29;

Article 10 (9)(h) Product Identification

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

Article 10 (9)(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 (9)(b) Regulatory and Standards Watch

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

Article 10 (9)(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 (9)(l/m) Data Analysis

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(c) responsibility of the management;

Article 10 (9)(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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