Service

Primara Test- und Zertifizier-GmbH

Gewerbestr. 28 , 87600 Kaufbeuren
Germany

Telephone +49 8341 99726-0
Fax +49 8341 9554894
info@primara.net

This company is co-exhibitor of
Bayern Innovativ GmbH

Trade fair hall

  • Hall 3 / E83
 Interactive Plan

Hall map

MEDICA 2016 hall map (Hall 3): stand E83

Fairground map

MEDICA 2016 fairground map: Hall 3

Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies

Technical equipment management, Test houses / Certification Bodies

  • 07  Medical Services and Publications
  • 07.10  Technical equipment management, Test houses / Certification Bodies
  • 07.10.02  Certification and testing of medical devices, quality assurance

Certification and testing of medical devices, quality assurance

Our products

Product category: Technical equipment management, Test houses / Certification Bodies, Certification and testing of medical devices, quality assurance

MEDICAL ENGINEERING

As a manufacturer of medical devices, you have to deal with continuously changing legal requirements in order to sell your products successfully and position yourself on the market.

In addition to the clinical use of your product, it is necessary to guarantee the safety of the patient and the user.

Depending on the risk category of your medical device, you need to take extensive precautions and undergo processes to meet the essential requirements of the European Medical Directive.

With exception of custom-made design and products that are intended for clinical investigation, medical devices have to bear the CE marking according to directive 93/42/EWG.

An important criterion is the examination of your product based on European harmonized standards for medical devices. Through international progress in standardization and technology, these standards are subjected to constant change on which you as a manufacturer always should keep one eye on. 
Primara can support you with the implementation of these requirements through independent testing.

As a DAkkS-accredited testing laboratory in accordance with EN 17025 for medical products, we have the knowledge of all standard requirements and of testing your product for conformity.

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About us

Company details

 

As a laboratory for medical devices, we support you in placing your product on the market.

The safety and reliability of your product is essential in order to be successful. Our aim is the sustainable development of safety and quality our your products as well as the uncomplicated and fast processing of market authorization.

Primara is a recognized testing laboratory for medical devices according to Directive 93/42/EEC and 90/385/EEC and DIN EN ISO/IEC 17025.

 

We offer tests for medical devices for example for the following standards:

 

  • IEC/EN 60601-1

2nd und 3rd edition

  • IEC/EN 60601-1-6

Usability

  • IEC/EN 60601-1-8

Alarm systems

  • IEC/EN 60601-1-11

Medical care in home environment

  • IEC/EN 60601-2-2

High-frequency surgical equipment

  • IEC/EN 60601‑2-4

Defibrillators

  • IEC/EN 60601-2-10

Nerve and muscle stimulators

  • IEC/EN 60601-2-25

E lectrocardiographs

  • IEC/EN 60601-2-26

Electroencephalographs

  • IEC/EN 60601-2-40

Evoked response equipment

 

Capture new markets with our support!

Through our OHSAS and SCC accredited partner QPS we can offer you a fast NRTL certification for Canada and USA.

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Company data

Sales volume

1-9 Mio US $

Export content

max. 25%

Number of employees

20-49

Foundation

2010

Area of business

Medical Services and Publications