Medtedow | Technical Documentation & Regulatory Support

Experienced technical documentation services for medical devices and SaMD. We support in managing the technical documentation for compliance to QMS pertaining to regulatory compliance for ISO:13485, USFDA, CE and CMDCAS. We support with strong expertise in writing documents to support design control, manufacturing processes and related audit clearances. We can assist you from initial requirements emerging from the ideation gatherings through to the technical requirement to the formulation of conformism in documentation with necessary validation documentation control and templates for records. Get our technical documentation as a managed service to support your technical documentation needs to free you of your technical documentation necessities enabling you to focus on research and business. Our technical documentation services provides: • Assembly overviews and Assembly documents • Brochures • Content management • Device History File • Device Master Files • Informed consent forms • Instructions for use • Manuals and guides for use and service • Online help • Operating, installation and maintenance manuals • Packaging and labelling • Patient questionnaires • Product catalogues • Product guides • Publishing • Quality Management System - ISO13485, 21CFR 820 • Quality Manual- ISO13485, 21CFR 820 • Quick reference guides • Risk Analysis as per EN/ISO 14971:2012 • Scientific articles • Spare parts catalogues • Technical authoring & illustrating • Technical Dossiers • Technical Files for CE Certifications • Training / e-learning • Usability File • Validation Master Plan • Validations Protocol • Work instructions

• Employees0
• Founded2015