This is how we look at quality and your safety
We take your safety seriously and we are proud to offer you products that have undergone rigorous testing, all for your safety. Therefore, all tests that Quicktest markets and sells in Scandinavia are CE-approved. Many of our tests are used in healthcare in Europe, the difference is that our tests are adapted for home use and that the tests are used by someone who does not have medical training. The tests are therefore exactly the same, what differs is basically the language used in the leaflet/manual.
Below describes in more detail how we work. We believe in openness and transparency and therefore we have chosen to show you how we work with quality control etc.
We require our manufacturers to present documentation on manufacturing date, expiration date, quality control, batch traceability, that personnel have adequate training and that manufacturers are ISO certified. They must also present documentation in Quality Assurance, this documentation must be fulfilled by the EU control body according to Annex IV section 5 – excluding Section 4 and 6 of the Council Directive 98/79/EC of the European Parliament for In Vitro Diagnostic Medical Devices. We follow the latest research on medical technology through participation in trade fairs and ongoing self-study of the latest findings in medical technology at various universities.
To ensure the above, our products are checked by an independent institute: mdc (medical device certification) which is a so-called Notified Body with control number 0483. Mdc medical device certification GmbH is based in Stuttgart – Germany. Their contact details are as follows:
mdc medical device certification GmbH
In addition to this quality label, we carry out ongoing self-checks. These controls include visits to manufacturers to ensure that they comply with ISO certifications and GMP (Good Manufacturing Practice).
We also require the manufacturer to show all quality protocols, this means that the tests undergo random sampling where sensitivity and reliability are checked by a third party, usually a laboratory that carries out the tests.
Our tests are stored at 18 degrees Celsius with minimal exposure to sunlight. Our customer service is always staffed by at least one Leg. Specialist Nurse (4 years of medical college).
In order to give you as a consumer adequate protection, we have designed a confidentiality and integrity policy, which gives you as a customer comprehensive protection. You can read more here.
This is Quicktest and how we look at quality and your safety. If you have any questions, you are always welcome to contact us - we are here for you.