What Is ISO 13485?
ISO 13485, Medical devices Quality Management Systems is the most necessary requirements for regulatory purposes, it is an globally recognized standard for all organizations involved and initiated in the medical device industries. Companies which are using compliance to their standard to obtain the certification in Quality Management System.
The primary purpose of the standard is to Harmonize of the Medical Device regulatory requirements of Quality Management Systems. The latest survey conducted by the International Organization for Standardization (ISO) shows that in 2015 that the number of ISO 13485 certificates issued worldwide was 26255.
How It Can Help?
The Voluntarily conforming set to ISO 13485 is one of the best approach that all companies have to prepare for an international vise market access. Being for your company provides stakeholders and business partners to build with the confidence that the organization has put all the efforts to conform to the standard.
Who should take this Certification?
The Certification in ISO 13485 is the proof of best Quality Management System compliance to the standard for the organizations which is involved in the Medical Device industry. This approach is not only followed by Medical Device Manufacturers but also all the supporting organizations such as Subcontractors, Suppliers, European Authorized Representatives, specialized Consulting firms etc.
Note that the certification in expands all the profile of companies and organizations with best and well versed to which the standard can apply: Organizations involved in one or more several stages of a Medical Device Life cycle or a Supplier or other External Parties providing such organizations with products for example.
Why is ISO 13485 Consultants Necessary
- To Improve your company image and credibility
- To Improve your customer satisfaction
- To Fully integrated processes
- To Use the best evidence-based decision making.
- To Create a unique culture of continual improvement
- To Engage your people
How to get ISO 13485 Certification
Expert certifier is a universal perceived ISO Certification Consulting organization for Our Consultants have in-depth involvement in executing the standard both crosswise over different businesses.
We help the organizations to execute the standards and be profited by its advice procedures. The standard prerequisite is made effectively reasonable to your association which makes the execution basic yet viable. Straightforwardness and expert counseling makes us extraordinary with quality administrations gave.