We guarantee the highest standards.
For more than 20 years we have developed, produced and distributed medical devices of various risk
classes in accordance with the European directive 93/42/EEC. When working with our suppliers and
collaboration partners, we insist upon the same extremely high quality requirements that we place
on our products. In addition to legally required monitoring measures we also conduct unannounced
inspections and regular audits. We don’t merely rely on certificates but also require compliance
with additional standards such as pharmacopoeia and GMP. Our detailed and customer-focused QM system at
ALBOMED® GmbH was first certified in 1997 and has been continuously adapted to increasing
requirements, particularly those in relation to CE certification. Our quality management system is subject
to regular internal and external audits.
The continuous further development of our processes, adaptation to market changes, the quickest possible
implementation of growing statutory requirements and not least the personal dedication of all our employees
ensure that we offer products of a consistently excellent quality at the highest level. In certifying our
quality management system, ALBOMED® GmbH also builds on German quality. ECM in Aachen –
a well-known “notified body” –
has been our reliable certification partner for many years.
ALBOMED® GmbH is certified according to DIN EN ISO 13485.
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