With the goal of customer satisfaction, Microptic is very committed to Quality. Both from the point of view of the distributor or the end customer, and from the point of view of compliance with legal requirements. Is for this reason that, despite being voluntary, Microptic decided years ago to be certified in ISO13485.

Why is Quality so important for an organization?

In order to compete in an increasingly demanding market, quality is an essential factor for the continuity of organizations. Moreover, quality management ensures high quality products and services. The ISO13485 standard, in its new edition 2016, provides many tools to manage, control and improve all the processes of the company, and Microptic is taking advantage of it. A good Quality Management System, QMS, is the best evidence that the staff of a company is working properly and as a team. ISO13485 requirements are strongly integrated and each one of us is highly committed to stablished quality policies.

What will happen in May 2022?

Apart from this voluntary compliance, there is another one that is mandatory, the Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. In May 2022, the new Regulation (EU) 2017/746 of the European parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices will replace the Directive, and this fact will have a lot of consequences. The new regulation is much more restrictive, the requirements are more, and clearly more difficult to meet.

The new rules to classify the IVD products will lead to a higher risk class in 80% of the products, so the intervention of the Notified Bodies will be greatly increased, and the CE mark will be harder to obtain.

To get that the commercialization of our products will not be affected, Microptic began to work on the adaptation on the new Regulation time ago, and now we can proudly assure that in May 2022 we will be able to maintain our activity, with the high level of quality as usual. Companies that have not been adapted to the new Regulation will not be able to market their products in Europe. Our customers and distributors can trust us, in our products and services, now and beyond May 2022.

Now more than ever… Microptic is your partner in semen analysis.

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