ISO 13485 Medical Devices Certification
Overview
ISO 13485 "Medical Devices – Quality management systems – Requirements for regulatory purposes" is a voluntary standard for the certification of quality management systems for organizations which design, develop, produce, market, install and service medical devices. The standard was published on 15 July 2003.
Objectives
Provide a means to develop quality management systems applied to organisations in the medical devices sector, in compliance with regulatory requirements.
In particular, for organisations which intend to market their products within the European Union, Vericert certification focuses on appropriate risk analysis and management associated with the use of the device, in line with European legislation.
Key points
Risk analysis, developed through an identification, assessment, prevention and assessment of residual risk approach; Communication – information to the user;
Management of the non conforming device from the point of view of certain traceability of the product and of its critical components;
Company management system; Process control.
How to certify your System
Application for certification by Organization.
The applicant must present written documentation of the fulfillment of the requirements.
The certification body appoints auditors.
The auditors inspect the work done at the organization.
After successfully completing the steps 1-4, the applicant obtains a certificate with the authorization to carry the mark of conformity. The certificate is valid for three years, as long as the requirements for the maintenance of the certificate are fulfilled.
Re-audit yearly, to verify the effective and universal quality of the service.
Why Certify?
Certification creates Trust
An independent institute certifies that a product, a service or person has been certified, fulfills the requirements of the respective standard and its quality is continuously monitored. This creates trust, also with your customers.
Set yourself apart
By being certified by an independent institution, you win competitive advantages. Thereby gaining the advantage over your competitors.
High Quality Standards
A certification indicates quality. With a valid certificate, you affirm your customers and business associates of the quality of your products and services.
Privileged Supplier
Certificates are often required for the (public) allocation of contracts. Take advantage of the chance to eventually belong to a group of privileged suppliers.
Use these Advantages to Ensure your Businesses' Success
Put the reference to your certification on your business papers and media of communication in order to make it public, thereby strengthening your customers' trust in your products and services.
For details about this service, please contact Vericert Certification