ISO 13485 / MDR document template:

Strategy for Regulatory Compliance

The purpose of this document is to define the processes for identification of relevant legal requirements, qualification, classification, handling of equivalence, and choice of and compliance with conformity assessment procedures.

The document is optimized for small and medium-sized organizations - we believe that overly complex and lengthy documents are just overkill for you.

There are 5 appendices related to this document. The appendices are not included in the price of this document and can be purchased separately: General Safety and Performance Requirements (GSPR), GAP Analysis, Statement for Custom Made Devices, Declaration of Conformity and List of Economic Operators and Authorities.

RELATED DOCUMENTS Related-Documents-Arrow List of Economic Operators and Authorities Related-Documents-Arrow Declaration of Conformity Related-Documents-Arrow Statement for Custom-Made Devices Related-Documents-Arrow GAP Analysis Related-Documents-Arrow General Safety and Performance Requirements (GSPR)
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RELATED DOCUMENTS Related-Documents-Arrow List of Economic Operators and Authorities Related-Documents-Arrow Declaration of Conformity Related-Documents-Arrow Statement for Custom-Made Devices Related-Documents-Arrow GAP Analysis Related-Documents-Arrow General Safety and Performance Requirements (GSPR)

DOCUMENT FEATURES

OVERVIEW

  • Price
    US$ 84.90
  • Compliant with
    MDR articles 8; 10(9); 15; 19; 25; Annex I; Annex IV; Annex IX; Annex X; Annex XI; Annex XIII
  • Format
    MS Word 2013, MS Word 2016, MS Word 2019
  • Number of pages
    10
  • Document language
    English

USABILITY

  • Can I edit the document?
    Yes. The document is fully editable – just enter information specific to your company.
  • Can I use this to become certified?
    Yes. The documentation template may be used for ISO 13485 certification audit purposes.
  • Well-defined instructions
    Document templates contain an average of twenty comments each, and offer clear guidance for filling them out.
  • Designed with your company in mind
    The template was created for small and medium-sized businesses.
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WHAT OUR CUSTOMERS SAY ABOUT US

The documents are well laid out and with our company’s standard formatting they are just falling into place.

Thomas Green

CBCP

Simple gave us an example of how the document could be structured and the different fields to include. Helped us not leave anything out.

Wynn Johansson-Nunez

SVENSKA DENTORAMA AB.

OUR CLIENTS

Strategy for Regulatory Compliance - 13485Academy
Strategy for Regulatory Compliance - 13485Academy
Strategy for Regulatory Compliance - 13485Academy
Strategy for Regulatory Compliance - 13485Academy
Strategy for Regulatory Compliance - 13485Academy
Strategy for Regulatory Compliance - 13485Academy

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  • The document is fully editable so that you can adapt it to your company design.
  • Documents include placeholder marks for all information you need to complete.
  • Each document includes comments and information, which guides you through completion.
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