What We Offer?

Medical Device Consulting And Regulatory Guidance

Medical Device Manufacturing Industry

Medical Device Turnkey Project Consultant

Medical Device Turnkey Project Consultant (Read More)
Medical Device Clean Room Design (Read More)
Medical Device Process Validation (Read More)

Manufacturing Site Conceptualization

Manufacturing Plant Layout Design (Read More)
Clean Room Design (Read More)
Medical Device Process validation (Read More)
Medical Device Equipment and utility validation (Read More)

Medical Device Regulatory Consultant )

ISO I3485 Certification (Read More)
US FDA Registration (Read More)
US FDA 510(k) Clearance & Premarket Approval (Read More)
US FDA 21 CFR Part 820 Quality System Regulation (Read More)
Import and Product Registration For Medical Device (Read More)

Medical Device Regulatory Consultant )

Primary Packaging Project Consultant (Read More)
Packaging Layout Design (Read More)
Clean Room Design (Read More)
Process Validation (Read More)

Primary Packaging Manufacturing Consultant

Packaging Layout Design (Read More)
Clean Room Design (Read More)
Process Validation (Read More)
Equipment & Utilities validation (Read More)

Primary Packaging Regulatory Approvals & Certifications

DMF File Preparation and Submission (Read More)
GMP Guideline
US DMF File Submission (Read More)
ISO 15378 Certification (Read More)

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 design control. 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.

US 21 CFR 820.30 Design Control Requirements

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

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