CE
CERTIFICATION
Unikal
Consultants specializes in consulting for CE Certification
of Medical Devices. For companies requiring a CE mark for
their product for exporting to the European Community Company
assists with interpreting the standard and outline the requirements
for obtaining the CE mark.
The
company gives complete guidance and advice from site preparation
to documentation e.g. Technical File preparation, implementation
of system as per MDD/93/42 and training to staff of Medical
Device manufacturers to obtain CE marking for their medical
devices. The company's completed and ongoing assignments
include Devices in class I (Sterile), IIa, IIb and class
III.
Technical File Preparation:
As part of the CE requirements a Technical File has to be
prepared to outline the safety requirements of the product.
Unikal will assist you in the preparation of the Technical
File to meet the review of the third party certification.
Selection of Certifying Body:
The CE Mark Certification requires a third party review
of the Technical file to assure conformity to the standard.
Unikal will assist you in the selection of this Certifying
Body, prepare the application and be present during the
certification audit.
AUDIT,
DOCUMENTATION AND GMP
Unikal advises Pharmaceutical Companies for c-GMP, WHO-GMP,
Documentation as per US-FDA and DMF preparation and Documentation
and Quality Assurance systems.
TECHNOLOGY
& KNOW-HOW
Unikal undertakes Active Pharmaceutical Ingredients (API)
and Pharma Formulation Projects. These include process setup
at laboratory scale and up-gradation to Plant scale, Production,
establishing QA systems and analytical methods development
& validation.
