ISO 13485 Templates

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Document Template
Sven Piechottka

Software Validation Form

Sven Piechottka
updated 9 months ago
Document Template
Dr. Oliver Eidel

Quality Manual, Policy, Objectives

Dr. Oliver Eidel
updated 9 months ago
Document Template
Sven Piechottka

SOP Management Review

Sven Piechottka
updated 9 months ago
Document Template
Dr. Oliver Eidel

SOP Document and Record Control

Dr. Oliver Eidel
updated 9 months ago
Document Template
Dr. Oliver Eidel

SOP Purchasing

Dr. Oliver Eidel
updated 9 months ago
Document Template
S

Internal Audit Report

Sebastian Skorka
updated 10 months ago
Document Template
Sven Piechottka

SOP Vigilance

Sven Piechottka
updated about 1 year ago
Document Template
Sven Piechottka

ISO 13485: Mapping of Requirements to Documents

Sven Piechottka
updated about 1 year ago
Document Template
Sven Piechottka

Supplier Checklist

Sven Piechottka
updated about 1 year ago
Document Template
Sven Piechottka

Training Record

Sven Piechottka
updated about 1 year ago
Document Template
Sven Piechottka

SOP Clinical Evaluation

Sven Piechottka
updated about 1 year ago
Document Template
Sven Piechottka

Incident Assessment Form

Sven Piechottka
updated about 1 year ago
Document Template
Sven Piechottka

Internal Audit Plan

Sven Piechottka
updated about 1 year ago
Document Template
Sven Piechottka

Internal Audit Program

Sven Piechottka
updated about 1 year ago
Document Template
Sören Hornof

List of Regulatory Requirements

Sören Hornof
updated about 1 year ago
Document Template
Sven Piechottka

Periodic Safety Update Report

Sven Piechottka
updated about 1 year ago
Document Template
Sven Piechottka

List of Medical Device Consultants

Sven Piechottka
updated about 1 year ago
Document Template
Sven Piechottka

Management Review Report

Sven Piechottka
updated about 1 year ago
Document Template
Sven Piechottka

List of Qualified Suppliers

Sven Piechottka
updated about 1 year ago
Document Template
Sven Piechottka

List of Training Documentation

Sven Piechottka
updated about 1 year ago