Certification: A 3-Party Process

Certification goes beyond assessing conformity to specifications and demonstrating interoperability across the ecosystem of Continua devices.  It is an ISO/IEC 17067 conformity assessment process that defines high value, transparent and objective methods and criteria for 3rd party certification of test results that are recognized worldwide.


Objective

The objective of Certification is to provide governments, health ministers, healthcare providers, or any other requesting entity an impartial 3rd party confirmation that the product under procurement, or under consideration or procurement, has successfully satisfied all conformity assessment criteria per this document.


Certification Body

PCHALLIANCE provides for 3rd party certification in CAS by Continua.  Continua operates in a competent, consistent, and impartial manner to the intent of ISO/IEC 17065.


Application

Application for certification is submitted directly to the PCHAlliance via the Continua Test Tool.


Test Execution

A Recognized Test Lab will conduct the testing required by the Certification Specification and report the results back to the product vendor.


Statement of Conformity

The CAS by Continua certification includes a statement of conformity explicitly stating the specific capabilities that have successfully passed all certification criteria and which representations can be claimed.


Fee Payment

CertAdmin will provide the member with a Certification Mark License Agreement and an invoice for the Continua listing fee. This is done after all certification testing issues have been resolved.


Granting Product Certification

Certification is granted upon verification of:

·      Member company is in good standing with Continua.

·      Official test lab results have been received.

·      Completed Certification Application has been received

·      Signed Agreements have been received.

·      Listing Fee (if applicable) has been paid.

Publicity

Certification requires passing all applicable tests. Once the certification process has been achieved, members receive a product certificate from CertAdmin and may then begin using the Continua Certified logo on their product, their packaging or any product literature (including Web pages).

All certified products are listed in the Certified Products Showcase.


Marks

Certification Logos are intended to represent to consumers that the associated product meets certification testing requirements which support interoperability in personal health devices to offer consumers a broad set of complementary products and services.

 

For more information, see Conformity Assessment Scheme by Continua.