ROCH Management Consultants LLP is a third party Consulting, Training and Audit organization. Our company's key expertise is providing Strategic regulatory consulting for Medical Devices manufacturers. We help our Clients to effectively navigate through the maze of obtaining CE certification of their medical devices. Our expertise in regulatory matters pertaining to Class II & III devices, helps in preparing Design Dossiers & TMFs which comply with the needs of Notified Bodies. We work with our Clients from start of the projects, to ensure that these requirements are taken into consideration from the get go. Our Services include: Preparing Design Dossiers and Technical Master Files for Devices Critical process Validation including Sterilization and Clean Room validation Clinical Evaluation Report (CER) Post Marketing Surveillance including Post Marketing Clinical Follow Up Risk Assessment Report Instructions for Use and Labels Incorporation of Design Change and demonstrate compliance with Essential Requirements Internal Quality Management System Audits and Mock Product Audits ROCH Manangement Consultants LLP is a Medical Device Consulting Company with considerable experience in Project management: