See new Medical Pack Solutions web-site: www.m-p-s.ie
Introduction
This site is intended to help the creation of
Medical Device packages that meet the demands of the market.
The Medical Device Industry is subject to
much regulatory control.
For those of us concerned with the
distribution of devices in Europe and the USA, the requirements of the Medical
Device Directives and the FDA are of prime importance. We must also comply with
various regulations and standards concerning such matters as environmental
impact, identification of package materials and the safe transport of dangerous
goods.
The USA has FDA rules that are effectively
mandatory.
The EU has its Directives with many Standards
that enable manufactures to demonstrate compliance with the Directives.
The content of some of the applicable standards are outlined in this site; many more appear in my Standards List.
Since June 15th 1998 it has
been illegal to place on the market in the EU any device that does not comply with the
MDD and carry the 'CE' mark.
If we cannot readily verify the quality of
each package then our package performance and packaging systems must be
validated.
Labelling must always meet prescribed
standards and provide product traceability.
See new Medical Pack Solutions web-site: www.m-p-s.ie