ROCH Management Consultants LLP

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:

Company’s Keywords:

accreditation management system certifications, project management, medical device development, regulatory consulting, accreditation amp management system certifications