Quality Assurance SystemQualitätssicherungssytem

The Labotect Quality Assurance System

Quality assurance or QA is seen by Labotect as an integral part of our quality management system. Every employee and staff member is made aware of the delicate environment our products are used in and need to accept these high standards set forth in our quality policy.

Approach

When developing our products we seek out the feedback and cooperation of renowned specialists in their respective field of work. Raw materials are chosen carefully to suit the purpose they are going to be used for. Mostly, this means they have to pass a test about biocompatibility, among others. Also, suppliers are chosen according to their proficiency at what they do. Each supplier must agree that he can be audited by us, our Notified Body and foreign authorities who might request this. The great majority of our suppliers come from Germany.

Various Tests

Before a batch of disposables is released it needs to pass a mouse embryo assay and a LAL-endotoxin test. Pass criteria are > 80 % blastocysts hatching in the mouse embryo assay and an endotoxin value of < 20 EU/Device. You will find these criteria to be one of the strictest in the industry. The tests are performed by an independent and accredited laboratory (Embryotech Inc.). Certificates are available on request.

Our CO₂ incubators play a vital role in different cell culture applications. To ensure their performance every unit has to pass a cell growth-test before it is released for sale.

Standards

Everything evolving around the design, development, manufacture and sale of our product conforms to at least the ISO 13485 standard with its already exacting demands. Additionally, we do fulfil requirements of many countries around the world, where our products are registered, e.g. Egypt, China, India, USA, Brazil, Croatia, Israel, to name but a few.

Reviews

Our quality management system is audited once a year and every three years we have to undergo re-certification. That means that at least two auditors turn our quality management system up-side down for 2 - 3 days.

Additionally, our notified body (TÜV SÜD Product Service GmbH) has long since implemented a policy to re-view the technical documentation for the products. It is compulsory for notified bodies since 2010 to prepare and implement an algorithm after which all products of a manufacturer in Class IIa and above are reviewed once a year.

Labotect has three product groups in Class IIa: our incubators, the aspirator and our ovarian biopsy sets and needles. So, within the validity of our ISO-certificate (three years) each product group is reviewed fully and within the validity of our EC certificate (five years) the relevant product groups are reviewed one and a half times.

Upholding these high standards takes a lot of time and effort but we feel that you and your customers deserve nothing less.

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