Medical Device Passport

A Passport to grow your Market

Focus 42 will partner with your organization during any phase of the medical device product life-cycle. We provide the full service for meeting all FDA Regulatory Requirements so you can access the largest markets.

Regulatory Strategy

Market research, intended use, device classification, and full strategy for FDA submissions.

Quality System

Create Quality Process, Documentation, and SOPs. Provide comprehensive quality and regulatory training.

Audit Remediation

Internal, pre-certification, and mock FDA audits with gap analysis. Manage external audits.

FDA Premarket Approval

Prepare applicable FDA submission packages. Liaison with FDA to secure product approval.

Product Launch

FDA registration, device listing, official correspondence, and U.S. Agent service. Product Labeling review and compliance (UDI).

Postmarket Support

Monitoring of all FDA required records, files, and submissions. Continuous improvement process.

Free Custom RA Proposal

It is ultra-convenient to evaluate whether we can fulfill your Regulatory Affairs Partner needs. Based on where you are in the life-cycle for your device, we will create a proposal for you. Your customized proposal is ready to download and evaluate in minutes, and there is no obligation.

  • Development

    For products that are in development, we offer you a custom proposal to meet FDA Premarket requirements in a timely fashion. Our efficient approach positions your product for a successful launch.

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  • Launch

    For products that are Exempt from, or already received FDA Clearance -or- Approval, we offer you a custom proposal for meeting the additional FDA requirements before your product can begin shipping into U.S. markets.

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  • Postmarket

    For products that meet FDA Premarket requirements for the U.S., we offer you a custom proposal for long-term sustaining services. This supports both you and your customers to meet FDA Postmarket requirements.

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FDA Regulatory Guidance

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    The need for effective cybersecurity to assure medical device functionality and safety has become more important with the increasing use of wireless, Internet- and network- connected devices, and the frequent electronic exchange of medical device-related health information.

    U.S. FDA
    Cybersecurity Regulations
    Learn more
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    FDA has established and continues to implement a unique device identification system to adequately identify medical devices through their distribution and use. Device labelers must also submit certain information about each device to FDA’s Global Unique Device Identification Database.

    U.S. FDA
    UDI Regulations
    Learn more
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    Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA.

    U.S. FDA
    Registration and Listing
    Learn more