Regulatory, Clinical & Quality Affairs for the MedTech Industry

©2019  H.M.Da Consulting & Development Ltd.

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Guiding you through the maze

HaMaDa Medical Devices and Life Science Consulting will guide you through the regulatory, clinical and Quality Assurance (QA) maze.

 

Our highly qualified team of professionals keeps completely updated on current global regulations and standards so that our clients can focus on their core business while being confident that they are getting the necessary professional assistance and support.  Our services include:

 

  • Regulatory strategy and Regulatory plans

  • Ongoing regulatory support for the timely approval of products marketed globally such as to the USA and Europe

  • .Manage the communication with regulatory authorities

  • Global Regulatory Consulting for Medical Device, combination products and IVD Companies

  • Design and assist in execution of clinical trials according to Good Clinical Practices (GCP)

  • Establishing, implementing and auditing quality systems

  • Compliance with Quality system requirements such as the US FDA QSR (21 CFR 820); ISO 13485

  • Verification and validation guidance, protocol preparation

  • Training and education

  • Labeling Review and Development

  • Due diligence – Regulatory, Clinical & Quality aspects for management, board members or investors

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