Is ISO 13485 Certification mandatory for medical devices ?

Is ISO 13485 mandatory for medical devices

Is ISO 13485 mandatory for medical devices ?

Just listen up!!

There won’t be any excuse if the medical device companies are not complying with the medical device quality system regulations!

On another note, the intention of the medical device company to get ISO 13485 certification in Bangalore itself will bring their focus on quality and will improve the image of company in the market. In order to avoid quality problems, optimize the design, and with the aim of development of the medical devices, every company must be in compliance with the ISO 13485 certification.

“A patient greatly depends on the safety, quality and consistency of the medical equipment”

The ISO 13485 can be used as a tool to do a thorough audit and to test the effectiveness of QMS. In this way, the organization can gain higher confidence by achieving a compliance with the compliance requirements.

Commitment to customers:

When it comes to the safety of medical devices, customers will believe on the credibility of the organization. Getting an ISO certification, will make the company more positive and will bring a permanent quality to the organization. This will strengthen the company when it comes to the products or services they provide.

“Emphasize on the safety and efficacy of medical devices”

Show yourself to the customers that you take ‘Quality’ more seriously and you have a certification to ensure that. Also, this has become a major requirement in many countries for the suppliers to show their compliance. The organizations can translate to more opportunity by improving their credibility and image.

But why ISO 13485?

This is known to be an international standard for quality management system in the medical device industry and is tested and proven. There are some quality management principles being set to build the ISO 13485 certification in Bangalore and one of them is to ensure the ‘customer satisfaction’. The processes for the improvements can be discovered easily to reduce errors and to facilitate more efficiency and cost savings.

Higher continual improvement will be achieved when the organization is in compliance with the ISO 13485 certification in Bangalore . Also, as an added advantage, there will be an increased insight to the health of your processes. There will also be an opportunity to lookout for the ways on improving how things are done. As this certification brings you a systematic process, you can save your time by reducing the problems and mitigating their effects as well.

Better employee engagement is also one of the reasons that any organization needs this ISO 13485 certification. The employees can understand their roles properly, thereby delivering the products and services with high quality. Keeping the employees more engaged will definitely bring you more efficiency and productivity!

Organizations involved in the design, production and installation can get this certification by responding to the latest quality management system practices   and the requirements and expectations as well. To the customers, stakeholders, patients, users and the regulatory agencies, this ISO 13485 will enhance the organizations’ marketability to typically meet the customer expectations.

By monitoring, maintaining and controlling the processes, the ISO 13485 standard will provide safety in the premises of standardization. You can save the time by avoiding the quality checks for individual processes and even that’s a long process too !

“Demonstrate your ability to provide the top quality medical devices and related services that are applicable to the regulatory requirements”

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