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QUALITY MANAGEMENT SYSTEM - ISO 9001 & 13485
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Unikal Consultants undertakes complete QMS documentation, training & implementation by Strategic Review and Planning, Pre Assessment Certification Review Audit, System Design and Documentation, Notified Body Selection.
The company conducts training sessions for various aspects relating to Quality Management like Assessor training, Kaizen, 5S etc. Company audits as their Internal QMS auditors. |
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| CE CERTIFICATION |
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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, the Company assists with interpreting the standard and outlining the requirements for obtaining the CE mark.
The company gives complete guidance and advice from site / plant compliance to documentation e.g. Device Master 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 for CE certification include Devices falling in class I (Sterile), IIa, IIb and class III. |
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| DEVICE MASTER FILE PREPARATION |
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| As part of the CE requirements a Device Technical File has to be prepared to outline the safety requirements of the product and risk management. Unikal will assist you in the preparation of the Technical File to meet the review of the third party certification. |
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| SELECTION OF CERTIFYING / NOTIFIED BODY |
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| 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. |
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| AUDIT, DOCUMENTATION AND GMP |
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| Unikal advises Pharmaceutical Companies for c-GMP, WHO-GMP, Documentation as per US-FDA and DMF preparation and Documentation and Quality Assurance systems. |
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| TECHNOLOGY & KNOW-HOW |
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| Unikal undertakes Active Pharmaceutical Ingredients (API) and Medical Device Manufacturing Projects. These include process setup at pilot scale and up-gradation to Plant scale, Production, establishing QA systems and analytical methods/process development & validation. |
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