Documentationconsultancy.com has reintroduced its fully customizable ISO 13485 Documents Toolkit, providing medical device companies with comprehensive, editable templates for efficient MDQMS implementation and ISO 13485 certification.

ROSWELL, NM, October 10, 2024 /24-7PressRelease/ -- The well-known document management solutions supplier for regulated industries, Documentationconsultancy.com, announced the relaunch of its valued Editable ISO 13485 Documents Toolkit. A quality management system for the design and manufacture of medical devices must comply with ISO 13485. Implementing and supporting an ISO 13485-compliant quality management system is necessary for ISO 13485 certification. A full set of required and supplementary documents is available in the ISO 13485:2016 Documentation Toolkit.

To generate documentation for companies, they offer ISO 13485 Documentation Consultancy. Businesses submit their details to us via digital platforms. Additionally, they support them via video conferences and web chat, which guarantees improved system installation and auditing and saves time and money when learning about the documentation and system implementation needs. A set of easily editable documents designed to meet ISO 13485:2016 criteria is available in the updated ISO 13485 documents Toolkit. By removing the requirement for businesses to start from the beginning, the crucial resource helps them save time and money when implementing MDQMS. With the help of the comprehensive toolkit, medical device manufacturers can speed up the creation and implementation of a strong Medical Device Quality Management System (MDQMS) that complies with the most recent ISO 13485 standards.

A collection of templates, including pre-made documents, are available in the ISO 13485:2016 Documentation Toolkit. The templates are meant to satisfy broad standard requirements. The readymade ISO 13485 documents include;
• ISO 13485 Quality Manual (40 pages)
• ISO 13485 Procedures (19 procedures)
• Exhibits (04)
• Blank Formats (61 sample forms)
• SOPs (06 sops)
• Process Flow Chart (12 Process flow charts)
• ISO 13485 Audit Checklist (More than 900 Questions)
• Medical Device File (21 files)

The ISO 13485 Documents Toolkit is a valuable resource for various organizations, including medical device manufacturers, contract manufacturers, design and development firms, companies seeking certification for the first time, and those transitioning from previous ISO 13485 versions.

The ISO 13485 documents toolkit gives users all the tools and direction they need to put the standard into practice. The materials, created by seasoned ISO consultants, are simple to use and comprehend, guaranteeing ISO 13485 certification while saving time and money on the documentation process. The ISO 13485 documents are written in simple English language. Users can edit the documents as per the requirements. For more information about the ISO 13485 documents toolkit, visit here: https://www.documentationconsultancy.com/iso-13485-documents.html

For all worldwide system and product certifications, as well as ISO certifications, Documentationconsultancy.com provides four-step online ISO documentation consulting. With over 2400 clients, the organization provides a team of expert consultants with extensive experience in building systems and/or documentation for ISO certification. Any organizations looking to become ISO-certified can get in touch with us to learn how to use the online documentation and certification consultation services to expedite the certification process and save costs. For this E-documentation consulting program, email, online conferences, and phone conversations will be the primary means of communication.

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