Certification

Ministerial Decision 1348

Interest Form

Please fill out the interest form

The Ministerial Decision DY8d/G.P.OIK./1348/2004 sets out the requirements for the observance of a system of principles and guidelines regarding the good practice of distributing medical devices in order to ensure that the products do not deteriorate and their quality does not deteriorate from the moment they are received by the supplier until the moment they are delivered to the customer.

The term medical device (Directive 93/42/EEC) refers to any instrument, apparatus, equipment, material or other article, used alone or in combination, including the software required for its proper functioning, which is intended by the manufacturer to be used in humans for the purposes of:

  • Diagnosis, prevention, monitoring or alleviation of disease
  • Diagnosis, monitoring, treatment, alleviation or correction of injury or disability
  • Investigation, replacement or modification of the anatomy of a normal function
  • Control of conception

Target Audience

All businesses trading and distributing medical products, regardless of legal form and size

The benefits it offers

Focus on Information Security, as a key component of effective privacy management, facilitating problem prevention and improving the system itself

Facilitating corporate communication between partners/customers regarding the management of sensitive personal information and avoiding its leaks

Strong commitment of each organization towards its customers/partners by gaining trust in matters related to personal data protection

Highlighting the corporate transparency of each company, regarding management and agreements with partners/clients, proof that appropriate measures have been taken to cover its corporate and legal obligations regarding data protection and privacy

The company that is interested in being certified according to Ministerial Decision 1348 scontacts BQC and fills in the certification application and send it to info@bqc.gr or fax it to +302112213726.

BQC is accredited by the Hellenic Accreditation System (ESYD) and issues internationally recognized Certificates. We cooperate with experienced inspectors and experts from all over the world, ensuring the most updated and professional knowledge in any business sector.

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