Quality Management & Regulatory Compliance

We provide quality management by establishing, maintaining or enhancing your quality systems according to ISO 13485, FDA 21 CFR part 820 Quality System Regulation and other relevant global QMS requirements.

Furthermore our solution consists of evaluating Quality processes and applying proven methodologies based on regulations to support you to implement best practices and meet computerized system validation (CSV) needs. 

The implementation of software as Medical Device is an essential and integrated part of our solution for our Medical Device customers.

Our solutions

your benefits

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Solution

  • Leading Quality Management/ GMP-projects to ensure regulatory compliance, with hands-on mentality (DIN ISO 9001 & ISO 13485) 

  • Conceptual improvement, optimization und harmonization of GxP- and quality relevant procedures for pharmaceutical or Medical  Device products 

  • Preparing Quality Management documents (SOPs & templates)

  • Document Management  

  • Planning and execution of trainings regarding guidelines (GMP, ICH, ISO-certification, GDP) in scope of national as well as international regulations   

Benefits

We ensure that your organization is equipped with a compliant Quality Management System according to ISO 13485 & ISO 9001. We provide you, if required, with all SOPs and templates, tailored to your needs.

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Find out more about our solutions, sucess stories and relevant topics.

Meet our expert

Nilofar Suha

Pharmacist / Senior Manager Quality & Compliance

By joining Digital Chameleon, Nilofar Suha serves her clients with a wide-range of highly specialized, independent Healthcare consulting services that empowers them to work better, faster and more profitably. She leverages 8 years of professional experience during which she acquired a deep knowledge of the key managerial and operational aspects of medical institutions in particular and the Healthcare industry as a whole. Being a certified pharmacist, and by focusing on advanced Lean Management methodologies, Nilofar Suha’s expertise goes beyond the Medical and Pharmaceutical sectors to serve a full spectrum of industrial and manufacturing clients. During her time at Fresenius Kabi, Nilofar Suha had the opportunity to put into action all her years of multi- disciplinary experience, developing Medical Devices for Nutrition and After Care in hospitals, and rehabilitations with key customers. Furthermore her expertise in the operational aspects of the medical sector allowed her to advise on product strategy, as well a plan and backlog for eHealth products, such as "Nutrition Manager" (NM), "Transition Manager" (TM) and "Marketplace" (MP). Her clients include Fresenius Kabi Digital Lab, Cantonal Hospital Basel and Röntgeninstitut Bellevue Zürich AG, Universitätsspital Zürich, Neuroradiology and Clinic Bogenhausen in Munich.

+41 (061) 311 54 01

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