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Services- ISO 13485

Address the International Regulatory Compliance for Medical Devices with ISO 13485 Standard.

ISO 13485

Address the International Regulatory Compliance for Medical Devices with ISO 13485 Standard.

What is ISO 13485:2016?


ISO 13485:2016 Standard confirms that medical devices used in healthcare industry are designed, produced, installed, and serviced to the highest standards. Already, business owner knows, these standards must not only meet client obligations, but also regulatory and legal requirements.


 Implementing ISO 13485:2016 into your business practices means you will build a clear, practical foundation to address these specifications, as well as demonstrate a commitment to safety, quality, and competence.



What are Benefits of ISO 13485:2016:


  • It takes control of your supply chain :  This standard confirms of whether the organizations in your supply chain are quality focused is to see if they are ISO 13485 certified. You are an original equipment manufacturer (OEM) of medical devices, so it is your responsibility to ensure that every producer within your supply chain is regulation compliant. Are they all working to identify risks and prevent defects in their own processes? Without ISO 13485:2016’s mark of quality, verification can be a tedious and unrewarding task.


  • It confirms the control processes are robust in every step of your product’s life : From development, to manufacture, to distribution, every stage of your product’s journey needs to be carefully controlled so that it meets regulation and avoids inadequacy at any step. ISO 13485:2016 makes the process less overwhelming by providing you with a solid, easy-to-manage framework to help you manage your control processes.


  • Reducing costs through a more efficient QMS : ISO 13485:2016’s carefully curated framework not only prioritizes best practices in the product journey, but also the efficiency of these practices. With a methodical approach to medical device manufacturing, you will have a logical plan for your workforce, saving time and reducing waste.


  • Becoming up-to-speed with the needs of regulatory authorities in your area : In a time when public health is at the forefront of everyone’s mind, authorities are more stringent than ever when it comes to regulating the medical device manufacturing industry. ISO 13485:2016 provides you with a useful framework that has already considered that there will be legal requirements associated with the medical device, so it makes these easy to control and manage.


  • Qualified with an internationally-recognized certification : ISO 13485:2016 is the leading qualification of its kind, meaning it is recognized across the world as a mark of quality and competence. Certification gives you confidence to emerge onto the global market and open yourself up to new business opportunities.


Steps to getting ISO 13485 certification


The Process of getting ISO 13485 certified with IMSM is a trouble-free step-by-step approach.


  1. Initial consultation
    We help you setting your objectives, focusing on what your business wants to achieve and how it defines success, specific in relation to your clients’ requirements. Together, you and our ISO specialist consultant will agree reasonable outcomes and delivery dates.


  1. Preparing your organization’s ISO 13485 documents
    Next, the Universal ISO Consultant will the gap analysis for existing procedures and help you document the new systems that will help deliver success – both existing and how you will improve these. This manual and procedures confirm how your business should operate going forward so that it can deliver Quality Management System ISO 13485.


  1. Training you to implement the ISO 13485 standard
    While the QMS documents are important document moving forward, it is even more important that it is placed to implement. We work with the top management team to ensure the ongoing framework is adopted throughout your organization.  We also develop and deliver customized training for staff to ensure understanding and implementation of ISO 13485 is meaningful. This will create consistency across your organization, transforming your business from day one so it is optimized for efficiency, continual improvement and greater profitability.


  1. Audit by an external certification body
    Before you can be awarded the ISO 13485 certification, your organization applies to the third-party certifying body that you have selected to conduct your audit. This audit is an objective view on whether your business is conforming to ISO 13485. As we will have provided excellent support and guidance to your business every step of the way, you can be assured that your ISO 13485 will be successful.


  1. ISO 13485 awarded
    Once confirmed that you are ISO 13485 compliant, your organization will be issued with the certificate. This international certification will be recognized by current, potential and future clients as a mark of quality.


Universal ISO is a reliable company that offers end to end ISO 13485 certification service. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. You can rely on experts at Universal ISO for ISO 13485 Consultants Services in USA.

It applies to all manufacturers and providers of medical devices, component manufacturers, contract service providers and distributors of medical devices.

An organization can be involved in one or more stages of the life cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).

Why ISO 13485 Medical Device Certification?

All medical devices that are manufactured in India or are imported into India have to either be licensed or registered on or before May 31, 2022.

Adopting ISO 13485 provides a practical foundation for manufacturers to address the regulatory requirements in different countries.

With an ISO 13485 certification, meet customer expectations better than your competitors.

Hire us and get our ISO 13485 consultant services in the USA.



Is it mandatory to achieve ISO 13485?


ISO 13485:2016 certification is not mandatory; although it brings your practices up to date with standard requirements that exist across the country, the EU and globally which very well may be mandatory.


How to get ISO 13485 certification?


Companies manufacturing medical devices often find that the consultancy of expert specialist helps them to easily implement ISO 13485:2016 into their core processes.

At Universal ISO, our consultants work directly with you to ensure your QMS works for your organization. We help you design your control requirements in line with the standard, then submit you to a recognized, third-party certification body who will audit your business and get you ISO 13485:2016 certified.


How much time it takes to achieve the ISO 13485 certification?


The time taken to get ISO 13485:2016 certified depends on the size, nature and complexity of your organization. It is estimated that it can take 6-8 weeks for companies with less than 50 employees. For larger companies, it can take 10-12 weeks as complex manufacturing processes like sterilization time consuming process.



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Related Services

ISO Certification Process


Conduct Gap Analysis


Providing Training to Management & Employees


Guidance Regarding Documentation & Implementation of QMS


Guidance on Conducting Risk/opportunity Assessment


Internal Audit by the Consultant


Guidance & Closure of Observations


External Audit by Certifying Body


Closure of External Audit Observations


Issuing Certificate

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