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Medical Device Turnkey Project Consultant Presented By
Operon Startegist, Pune
Contact No: +91-9823283428 Website: www.operonstrategist.com
Email-id: [email protected]
Scope of Work For Turnkey Project
As Medical Device Project ConsultantsWe provide a complete package of
turnkey services including: Facility Design & Layout Clean room conceptulization Validation QMS implementation Documentation & training Local liasoning - CDSCO Certification Reqd. certifications & Regulatory
Approvals for international marketing.
Post marketing support
Main Aspects to be considered
• Facility Design & Layout
International regulatory and cGMP requirements consideration. To consider the regulatory approvals required. To determine the space requirements for various processes and their associated equipment / machinery. To ensure unidirectional flow of man and material and prevent cross contaminationTo consider future expansion.
Main Aspects to be considered:• Clean Room Conceptulization
To evaluate the product and accordingly design of clean room. Selection - Class 1 to Class 100,000 considering ISO 14644 clean room standards, product & regulatory requirements. The classified areas are also reflected in the factory layout design to give a better clarity to the client about classified & unclassified areas. To coordinates with clean room providers to convey the exact requirements to prevent any miscalculations while designing the clean room.
ValidationValidation is an important cGMP requirement & many regulatory agencies audit the validation documentation. Validation is carried out to ensure that products of consistent quality are manufactured and required level of compliance is met at every stage.
We assists for the following validation : Facility validation Utilities validation Equipment validation Process validation Microbial validation Software validation
Certification & Regulatory Approvals
Medical Devices are highly regulated products & different countries have a different regulatory approach for market clearance & sale of medical devices. Medical device vary in size, ease of use, safety ranging from simple bandages, surgical instruments to implants & complex systems involving software.
When a manufacturer decides to enter into a new market, he has to consider not only the regulatory requirements of that particular market, but also has to determine how those requirements apply to his product. Depending on the risk of the product & intended use, the regulatory requirements will vary.
Certification & Regulatory ApprovalsWe Provide Following Regulatory &Certification Services For Medical Device Manufacturers : CDSCO Regulatory for Importers and
Exporters CDSCO approvals ISO 13485 ISO 15378 CE Marking USFDA establishment registration USFDA – 510 (k) listing 21 CFR 820 TGA ANVISA
Post Marketing SupportPost-Market Surveillance (PMS) is the practice of monitoring the safety of amedical device after it has been released on the market. Post-market surveillance is collection of processes & activities used to monitor the safety & effectiveness of medical devices.We Provide Medical Device Post Market Support includes Following stages: Ongoing system and maintain the compliances during ongoing commercial
manufacturing process. CAPA compliance. Audit Report & Compliance. Labeling Compliance. Clinical Evaluation. Medical Device Reporting. Customer Complaints.
Our Clients Our Global Presence & Satisfied client are Worldwide.
Tradline Medical Laboratory ,Texas,USA Cognizant Technology Solutions Ltd, Pune Mediequip Verticals,Pune Cilicant,Pune Prasad Meditech,Pune Aavanira Biotech Pvt Ltd ,Pune RCH Orthopedics, Mumbai Australian Orthopedics India P. Ltd. Pune Neo Surgical, Rajkot Ortho Care & Cure, Kolhapur Medevice Manufacturing India Pvt Ltd, Aurangabad
Thank You
