FDA Services Page, OutlineTechCopywriter for Netspective

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Make Sure-Footed Progress through the FDA Compliance ProcessDo changes in FDA programs and new guidance documents make compliance feel like you’re hitting amovingtarget?With inspections, warning letters, recalls and UDI data, regulatory oversight of themedical deviceindustry is at an all-time high. And compliance is gettingmore difficult in keymarkets, including the USA.

Netspective consulting services streamline and reduce the effort and costs of supporting FDA/510(k)compliance programs. We work with: Manufacturers of next-generation medical and digital health devices. Providers of legacy healthcare IT. Non-US medical device manufacturers, who want to enter the USAmarket.

We design our products and services to help you: Identify and meet FDA expectations throughout the commercialization process. Stay legal, no matter how often requirements change. Maximize your opportunities in the USAmarket.

GETAQUOTE (button) Find out howour comprehensive, affordable FDA assessment services are

Methods that Hold Up to Scrutiny and Changing StandardsNetspective™ Opsfolio® Audit for FDA is our basic consulting service. This assessment provides thecompliance guidance and insight you need to meet current FDA standards with confidence. Use the audit to:

Gain a thorough understanding of 21 CFR 820 Quality Systems Regulation requirements.

Successfully navigate the FDA regulatory landscape by earning how to submit applications that arewell prepared, organized, and thorough.

Build and maintain a compliance program that satisfies current requirements.

Easily manage assets and processes when standards change.

Each audit uses our standard assessment method, which includes description of your complianceenvironment, testing, a gap analysis and risk identification and mitigation.

In FDA audits, our consultants:

Evaluate the classification of the medical device to identify the appropriate regulations.

Identify predicate devices that are similar and already have a FDA 510(k) clearance and judgewhether these devices can be used in your submission.

Review FDA compliance guidance and standards, testing and other specific requirements needed toclaim substantial equivalence to predicate devices.

Evaluate the documentation you have and additional materials you need to prepare and submit a510(k) Premarket Notification to the FDA.

FDA Services Page, OutlineTechCopywriter for Netspective

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[FDA APP SERVICES SUB-PAGE]FDA Application ServicesWe provide application services for medical device and medical IT manufacturers. Use it to customize yourFDA compliance program. These standard, cloud-based services are available by subscription. They include: Opsfolio SaaS for FDA: This version of Opsfolio for FDA QSR is the application used by people who

want to track, document and audit their operational assets and users for FDA QSR compliance.

Opsfolio PaaS for FDA: This version includes the APIs, which third-party developers can use to add ordelete capabilities to your instance of Opsfolio SaaS for

Opsfolio Mobile for FDA: This version adds Opsfolio PaaS functionality to your iOS and Androidphones and other mobile devices and connects them to your information platform.

Opsfolio CM for FDA: (Continuous Monitoring) : Continuously monitors the client environment forensuring FDA QSR compliance. Identifies and notifies changes that result in deviations from FDA QSRcompliance requirements.

Quality-Centered Product Development Services and SupportWith the FDA focus on process QA, the Netspective Unified Process (NUP) is a timely addition to our servicelineup.NUP is a complete, platform-based, QA service, which you operate online. NUP provides a wealth of guidance, tools and templates to help you comply with FDA regulations

and ISO 13485. It’s simple to use and easy to set up. Based on your requirements, we can have an online instance set

up and running within a week.

Use NUP in your product development efforts.

Premarket Approval and Notification SupportAnd if your device requires pre-marketing clinical trials, we also provide consulting services, which supportthe premarket approval or notification (510k) process.Our consulting services can help you build and maintain a flexible, up-to-date FDA compliance strategy thatwon’t strain your R&D budget. To find out how, contact us today at info@netspective.com. Or, call us at[telephone number].