Legal requirements
As of
June 13th, 1998 the EU guideline 93/42/EWG is effective. This regulation for
the manufacturing industry shall significantly improve the quality of
specific medical products. "To comply with the legal requirements" has to be
the guideline for the manufacturing and/or trading industry of medical
products.
Please find the following Certificates:
- DIN EN ISO 9001:2000
- DIN EN ISO 13485:2003 (former 46001)
- EU-guideline 93/42/EWG Annex V + II
- IQ-NET
For all sterile products miro is certified after EU
guideline 93/42/EWG:
Annex V (sterile, class 1/s) and
Annex II (sterile, class 2/b).
Additional standards of quality control management
Besides these stated norms our management has
added two additional chapters. These chapters are for finance/book-keeping
as well as environment protection.
