What We Offer?

Medical Devices Manufacturing And Regulatory Consultant

Primary Packaging Manufacturing Industry

Turnkey Project Consultant

Primary Packaging Project Consultant

Plant Layout Design

Clean Room Design

Process Validation

Primary Packaging Manufacturing Consultant

Plant Layout Design

Clean Room Design

Process Validation

Equipment & Utilities validation

Equipment selection & sourcing

Primary Packaging Regulatory Approvals & Certifications

DMF File Preparation and Submission

GMP Guideline

US DMF File Submission

ISO 15378 Consultant

Medical Device Turnkey Project Consultant

Medical Device Turnkey Project Consultant

Clean Room Design

Process Validation

Manufacturing Site Conceptualization

Facility Layout Design

Equipment selection & sourcing

Clean Room Design

Process validation

Equipment and utility validation

Medical Device Regulatory Consultant

ISO I3485 Consultant

US FDA Registration

US FDA 510(k) Clearance & Premarket Approval

US FDA 21 CFR Part 820 Quality System Regulation

Import and Product Registration For Medical Device

Medical Device Manufacturing Industry

Medical Device Product Design and Development

Medical Device Design & Development

Medical Device Design and Development failure in any product is a major non-compliance & may result in adverse events affecting users. During the design and development stage of the Medical device design, we assist various Medical device manufacturing industries to ensure that appropriate steps are taken to meet regulatory compliances of the Medical device design and development.

US 21 CFR 820.30 Design Control Requirements

After conceptualizing a new medical device, the next step in its product advancement is the design. This is the most important stage in the advancement of a medical device since a defective plan may prompt it being inadequate or dangerous (that is, not affirmed or cleared by the administrative organization).

The idea of Turnkey Project Management (TPM) for complex technical and construction projects is to reduce the client’s costs and the effort for observing, individual coordination and planning to a minimum. Medical device Turnkey project management means that our clients will receive a total turnkey approach to their investment project. Under the project idea, the Project need will be included and completely responsible for all technical coordination tasks with all other trades and client users.

Project Management for Medical Device Design and Development

Project managers must understand the development process and the key aspects of the stage door stages and configuration control prerequisites with a specific end goal to have the capacity to design and execute adequately. Effective completion of the product requirements gathering, product design, verification, and validation are key project milestones.

Medical Device Turnkey Project Management

Turnkey-Project-Management

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