ISO 13485 Certification

ISO 13485 Certification

ISO 13485 Certification, Medical devices – Quality Management Systems – requirements for regulatory purposes, is an internationally recognized standard for organizations involved in the medical device industry.  Companies are using compliance to this standard to obtain the certification of their Quality Management System. The primary purpose of the ISO 13485 standard is the Harmonization of the Medical Device regulatory requirements for Quality Management Systems. The latest survey conducted by the International Organization for Standardization (ISO) shows that in 2015, the number of ISO 13485 certificates issued worldwide was 26255.

Who can be ISO 13485 certified?

The ISO 13485 certification is a proof of Quality Management System compliance to the standard for organizations involved in the Medical Device industry. This approach is not only followed by Medical Device Manufacturers but also supporting organizations such as Subcontractors, Suppliers, European Authorized Representatives, specialized Consulting firms etc…

What are the benefits of being certified to ISO 13485?

Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.

• Increase access to more markets worldwide with certification
• Outline how to review and improve processes across your organization
• Increase efficiency, cut costs and monitor supply chain performance
• Demonstrate that you produce safer and more effective medical devices
• Meet regulatory requirements and customer expectations

ACHIEVING ISO 13485 CERTIFICATION

• We can also provide a no-obligation competitive quotation from our dedicated business development team.
• Our leading auditors will devise a comprehensive assessment program which will be agreed in line with your requirements.

CERTIFICATION BENEFITS

• Eligibility for submitting tenders or proposals for projects.
• Evidence of adherence to legal and regulatory or contractual requirements
• Generates new business opportunities
• Can boost your organisation’s brand reputation and be a useful promotional tool, especially when going up against competitors who aren’t certified
• Guarantees high quality of provided services and products
• Reduces production loss rate
• Reduces operational costs
• Increases effectiveness across the whole organisation
• Increases your customers‘ trust in you as a safe supplier or producer
• Minimize corporate risk

Our advice, go for it!!!

If you are looking or thinking on how to get ISO 13485 certification in India you can reach out to us. You can partner with us on consulting the standard requirement. We help our customers to consult free of cost. You can reach out to us at or write to us on contact@expertcertifier.com with your entire certification requirement. Also, you can feel free to visit our official website at www.expertcertifier.com and provide your contact details so that one of our Consulting experts can contact you in order to understand more about your process so that we can perform a free gap analysis. We are available 24/7 for all of our customers.