Medical Device Project Consultant

Service Details:

Medical Device Regulatory Consultant Service offered comprises services handled by experienced industry professionals who have with them rich experience as well as in-depth process knowledge to successfully meet the regulated medical device consultancy requirements. As regulations and requirements vary by country, our experts help clients in gaining a deep understanding of applicable regulations and requirements as per the published guidance documents.

Some of the features include

• Work with clients in designing and implementing competitive and cost-effective regulatory strategies
• Help clients in negotiating with FDA, EU as well as other international regulatory agencies
• Taking into consideration current regulatory environment and relevant guidelines that support clients in meeting the compliances
• Our regulatory experts consider information about medical device, including device description and specifications, available test data, literature references and others

Service Details:

Medical Device Manufacturing Consultant Service offered comprises services handled by experienced professionals from the industry who keep themselves updated regarding the growth of medical device market so as to correctly guide clients in meeting the required GMP, FDA and other industry regulations. Further, our team also takes care of areas like process validation including software code, manufacturing data and other things that can pose a possible hurdle in the proposed development and introduction of the new medical device.

Some of the features include

• Preparing clients for FDA inspections
• Data collection and reporting
• Machine and facility validation
• Making clients aware of key drivers at time of device introduction
• Maintaining good manufacturing practices and internal audits

Service Details:

With the years of experience and vast knowledge, we are engaged in offering Medical Device Turnkey Project Consultant Service to meet the demands of our customers. The study and survey before the consultancy services is being done for excellent services.

Medical Device Turnkey Project Consultant Service:

• Facility (Plant) Design
• Facility (Plant) built up
• Regulatory Liasoning
• Medical device Consultant

 

Regulatory:

• USFDA 510 (k)
• 510 K file preparation
• File submission
• Establishment registration and device listing
• US agent appointment
• Medical Devices
• China FDA registration
• GMDN number assessment
• US agent appointment
• EU Agent appointment

Quality Assurance:

• Current Good Manufacturing Practices (cGMP): GAP ANALYSIS and Implementation as per requirements of
• USFDA ( 21 CFR Part 820)
• Europe (CE requirements)
• WHO-GMP
• CDSCO (Indian FDA)
• ISO 9001: 2008 Consultant
• ISO 13485: 2003 Consultant
• Quality Assurance
• Audit Compliance of
• USFDA (21 CFR Part 820)
• Europe ( CE requirements)
• WHO-GMP
• CDSCO ( Indian FDA)
• ISO 9001: 2008
• ISO 13485: 2003
• CAPA Management System
• Change Management System

Validation:

• Equipment Validation
• Utility Validation
• Microbiological Validation
• Process Validation
• Cleaning Validation
• Analytical Method Validation

Certifications:

• ISO 9001 : 2008 : Quality management System
• ISO 13485 : 2003 : Quality management system - Medical devices

Training:

• Current Good manufacturing Practices.
• Equipment And Utility Validations
• Microbiological Validation
• Cleaning Validation
• CAPA Management System
• Change Management System

Third Party vendor audits:

• Third Party vendor audits on behalf of Company

Service Details:

We are a leading and trusted name involved with providing Medical Device Project Consultancy Service for Medical Disposables to a large number of clients across global markets. We expertise in providing services for various grain-based projects for both new plants and modernizations.

Service Details:

operon strategist helps clients develop, implement & maintain an efficient quality management system. we do an initial gap analysis of the existing system to determine the extent of development of the quality system.

 

we are regulatory project consultant service provider for medical device disposable implant manufacturers , medical disposable syringe manufacturers , medical devices & surgical  instrument manufacturers,orthopadic implant design consultant , laboratory equipment manufacturers , sterilization equipment and accessories manufacturers , medical imaging systems manufacturers
we also train the employees on the requirements of the quality system & channelize the system for continual improvement.we guide the clients through documentation & help them to effectively implement it through the various functions of the company.

Service Details:

Leveraging the skills of our qualified team of professionals, we are instrumental in providing Manufacturing Unit Design Service to our customers. This Manufacturing Unit Design Service is rendered by our imaginative designers keeping in mind the exact needs of our precious clients along with the necessary requirement of Regulatory Norms.

Service Details:

Being a customer focused organization, we are engaged in offering a wide assortment of Medical Device Technology Transfer Service. The offered range is manufactured using the excellent quality material so that these are in compliance with international quality standards.