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Accreditation EN ISO 13485:2021

Application for inspection of manufactured products according to annex IV.6 of Directive 98/79/EC

Clinical Evaluation (medical devices) – Structure and contents

Data protection information for customers and interested parties

Designation_IVDR

Designation_MDR

General Rules for Certification Procedures

General Safety and Performance Requirements according to Annex I of Regulation (EU) 2017/745

General Safety and Performance Requirements according to Annex I of Regulation (EU) 2017/746

General Terms And Conditions – Seminars

General Terms of Business

Guideline for the submission of electronic instructions for use

Guidelines for digital submissions

Information electronic signature

List of critical suppliers / OEM-Manufacturers (DIR, standards)

List of forged certificates / Liste Zertifikatsfälschungen

List of In Vitro Diagnostic Medical Devices (IVDR)

List of Medical Devices (MDR)

List of products – In-vitro Diagnostic Devices (CE 0483)

List of products – medical devices (CE 0483)

Notification of Change (MDR)

Notification of Change (Regulation (EU) 2017/746)

Notification of Changes (MDD/IVDD)

Notification of Changes (QM Standards)

Power of Attorney/Vollmacht

Price List – Certification according to Regulation (EU) 2017/745 (MDR) & Recognition in Third Countries

Price List – Certification according to EC Directive 98/79/EC (IVDD)

Price List (Certification according to IVDR)

Price List (Certification According to QM Standards)

Privacy information for job application

Privacy information mss 2.0

Privacy policy for IT-supported audio-/video conferences

Process Description “Technical Cooperation Programme” (TCP) – Taiwan

Process Description Certification of Quality Systems

Process Description Cooperation Procedure for Approvals in Ukraine

Questionnaire for a quotation – In-vitro Diagnostic Devices

Questionnaire for a quotation – Medical devices

Questionnaire for a quotation – Medical devices – Appendix II: Questionnaire Medical Devices class Ir (if applicable)

Questionnaire for a Quotation (Opinion under Regulation (EU) 2017/745 Article 117)

Questionnaire for a Quotation (QM Standards)

Questionnaire MDSAP (Basic Data) – DQS

Questionnaire MDSAP (Basic Data) – Guidance: How to comlete

Rules for certification procedures according to Regulation (EU) 2017/745

Rules for certification procedures according to Regulation (EU) 2017/746

Specific Regulations for Certification Processes according to MDD 93/42/EEC and IVDD 98/79/EC

Structure of Technical Documentation (Medical Devices)

Technical Documentation (In-vitro Diagnostic Devices)

Technical Documentation (In-vitro Diagnostic Devices) – File Structure (ZIP)

Technical Documentation (Medical Devices) – File Structure (ZIP)

Technical Documentation (Medical Devices) – Reusable surgical instruments (class Ir)

Use of Certification, Certificate and Certification Mark

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