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A-F

Aging, Conditioning and Transport-IVDR

Aging, Conditioning and Transport-MDR

Basic UDI-DI procedure-IVDR

Basic UDI-DI procedure-MDR

Business Profile

CAPA Escalation Procedure-IVDR

CAPA Escalation Procedure-MDR

CAPA procedure-MDR

Closed Loop PMS Roadmap-IVDR

Closed Loop PMS Roadmap-MDR

Complaint Handling, Distributor

Complaint Handling, Importer

Complaint Trend Analysis Template-IVDR

Complaint Trend Analysis Template-MDR

Corrective Action and Preventative Action Procedure-IVDR

Corrective Action and Preventative Action Procedure-MDR

Customer Feedback Procedure-IVDR

Customer Feedback Procedure-MDR

Data Analysis Procedure-IVDR

Data Analysis Procedure-MDR

Data Analysis-IVDR

Data Analysis-MDR

Design Controls-IVDR

Design Controls-MDR

Device Master Record Template

Device Master Record Template-MDR

Distributor Supply and Quality Agreement?-MDR

Document Control-IVDR

Document Control-MDR

Economic Operator Procedure, Distributor

Economic Operator Procedure, EU Manufacturer

Economic Operator Procedure, Importer

Economic Operator Procedure, Non-EU Manufacturer

Equipment Qualification Procedure-IVDR

Equipment Qualification Procedure-MDR

Field Safety Notice/Field Safety Corrective Action Procedure-IVDR

Field Safety Notice/Field Safety Corrective Action Procedure-MDR

Form, Health Hazard Analysis-IVDR

Form, Health Hazard Analysis-MDR

Form, Vigilance Assessment-IVDR

Form, Vigilance Assessment-MDR

FSCA/FSN/Recall, Distributor

FSCA/FSN/Recall, Importer

G-K

Health Hazard Analysis Procedure-IVDR

Health Hazard Analysis Procedure-MDR

Identification Handling/Storage

Implementing Transition Requirements, Quality Plan-IVDR

Implementing Transition Requirements, Quality Plan-MDR

Initial Registration, EUDAMED for EU Importers

Initial Registration, EUDAMED for EU Manufacturers

Initial Registration, EUDAMED for NON-EU Manufacturers

Job Descriptions/Competency with PRRC and EUDAMED roles define-IVDR

Job Descriptions/Competency with PRRC and EUDAMED roles define-MDR

L-P

IVDD to IVDR QMS Transition, Quality Plan-IVDR

Marketing Specification

Marketing Specification-MDR

Material of Concern Evaluation Process-IVDR

Material of Concern Evaluation Process-MDR

Materials of Concern (MoC) Editable List-IVDR

Materials of Concern (MoC) List-MDR

MDD to MDR QMS Transition, Quality Plan-MDR

MDR Transition Plan-MDR

Measurement System Analysis-IVDR

Measurement System Analysis-MDR

Normative/Standards Watch-IVDR

Normative/Standards Watch-MDR

Packaging Validation Plan-IVDR

Packaging Validation Plan-MDR

Phase Review Form

Phase Review Form-MDR

PMSP Procedure-IVDR

PMSP Procedure-MDR

PMSP Template-IVDR

PMSP Template-MDR

Post Market Surveillance Procedure-IVDR

Post Market Surveillance Procedure-MDR

Preventative Maintenance-IVDR