№ lp_1_2_16678
Procedural document detailing the submission and evaluation of significant changes for TÜV Rheinland QMS medical device certificates.
Year: 2026
Region / City: International
Subject: Medical device certification and significant change notifications
Document Type: Procedural guideline / Notification form
Organization: TÜV Rheinland Certification Body
Target Audience: Medical device manufacturers and authorized representatives
Applicable Standards: EN ISO 13485, MDD, IVDD, MDR, IVDR, UK MDR, MDSAP
Submission Requirements: Significant change details, supporting documents, technical documentation
Evaluation Process: Initial evaluation, potential on-site audits, cost information
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.

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