ISO 13485 - Maintaining the quality of medical devices

With an increase in population all over the world, public health has become an issue of major concern for the government of any country. Public health now-a-days just cannot be ignored at all. For this, a huge number of medical facilities have been set up in almost every country. And the government puts a huge importance on the topic of public health.

There is another aspect related to the public health. A sector which is growing rapidly and largely in stature and importance is the sector of medical devices. Medical devices are an integral part of the medical system. It’s impossible to move ahead without them. But there is also a growing concern over the quality of the devices.

To answer these, the Iso 13485 has been implemented. It is the Medical devices quality management system. The guidelines and requirements that are needed to maintain quality has been specified by the standard. In some countries though, only ISO 13485 is not enough for selling a medical device. It also requires clearance from the local body.

Benefits of ISO 13485 certification:

The benefits of the ISO 13485 certification can not only be seen in present but also in the future as well. It allows an organization to provide quality services to its customers. The benefits include-

• Compliance to quality- The certification ensures that the products, in this case the medical devices are compliant to the quality standard set by it.
• Quality improvement- It makes sure that there is constant process within the organization to improve quality of the product. This also means that there are technological up gradation within the organization.
• Meeting requirements- The certification also ensures that the medical devices meet the requirements set up by the local regulatory as well.
• Reliability- It enhances the credibility and trustworthiness of an organization making it much more reliable among public.
• Brand Image- The certification enhances the brand value and corporate image of an organization. This helps hugely in building a reputation and in extending business further.
• Satisfaction - It ensures that all the certified products are up to the mark. That brings customer satisfaction.
• Safety - The products are tested and checked thoroughly making them safe to use. This enhances consumer safety.
• New markets- The certification raise the sales up with ease and also open the door to new markets.

Organization requiring the certification:

A lot of organizations require ISO 13485 certification. It includes a manufacturer, distributor, supplier, retailer or any other organization that deals in medical devices.

Requirements for certification:

There are some key the requirements that are needed to be fulfilled for certification of ISO 13485 to be completed successfully. They include –

• A plan must be determined for the medical devices
• The quality management system must be identified
• All the required documents must be prepared in proper order for the successful certification
• The medical devices should have a proper maintenance process and schedule
• The devices must be sanitized in due time
• An internal audit must be done on yearly basis

Role of Ascent EMIRATES in ISO 13485 certification:

Ascent EMIRATES is a leading consultancy for the ISO 13485 certification in Dubai. It comes with twenty two years of experience in successfully consulting various organizations around the world. Ascent EMIRATES also has its presence in Sharjah, Abu Dhabi, Ras-al Khaimah, Ajman, Al Ain and Fujairah. It has an enormous network of experienced consultants and has been involved in thousands of successful certifications throughout the world. It helps an organization in understanding requirements of the certification.

Often, many organizations, especially the medium and large sized ones, avoid the certification procedure due to the complicated technical requirements. But, the positives of the certification hugely undermine the negatives. This is where Ascent EMIRATES excels.

Ascent EMIRATES provides an improvement in services and relationships within and outside the organizations. It keeps transparency to the clients and also advises them on the ways to improve. It works with large organizations as well as SMEs. It also trains personnel within the organization on the conformity needs and procedure of certification. It also steers an organization to resolve the problem regarding inadequate resources.

Ascent EMIRATES, through its effective advisory, helps organizations to cut down the ISO 13485 certification cost. It also trains personnel within the organization on the conformity needs and procedure of certification.

So, to obtain, ISO 13485 certification cost in UAE for your product, contact Ascent EMIRATES.

Ascent has strong specialization in ISO Certification with over decades on handling clients globally. Our auditors work both smart and hard to implement proven technical frameworks ensuring your company to keep up with complying ISO standards in UAE.