About Unikal Consultants

Unikal Consultants, a leading Consulting Organization is an Integrated Service Provider to the Corporate Clients

Special focus of Unikal's Technical team of Specialists is providing Consulting Services for Implementation of Quality Management system as per ISO 9001 & 13485; MDSAP, GMP & WHO-GMP, focusing on medical devices manufacturing facilities. Services are offered globally. Support for complete documentation, Internal audit and gap analysis, training of staff

Product certification like CE marking, and for, FDA Pre-market Notification 510(k) Submissions, for Medical Devices of all classes and Drug Device Combination products. Support for Medical Device related documentation, design & device studies, clinical and pre-clinical evaluation, Risk Management, Product evaluation, Usability studies.

European Authorised Representative support services & USA 510(k) Agent services.

Project consultancy for medical device manufacturing facility setup, evaluation and updating present facility to the requirements of MDR Europe, MDR India and FDA standards, including inputs on clean rooms, quality assurance and quality control facilities.