As a team well-versed in regulatory compliance, Netsepctive provides step by step guidance to medical device firms of all sizes to meet their 510(k) compliance requirements.Call Us on 111-111-1111
Developing a regulatory strategy
Our service establishes a clear and well defined strategy to help customers evaluate what they have in terms of documentation and what additional documents or artifacts they will be need to prepare and submit the 510(k) Premarket Notification to FDA.
Our Compliance Assessment Service helps:
- Evaluate the classification of the medical device in order to Identify the appropriate regulation.
- Identify predicate devices that are similar and which already have a FDA 510(k) clearance and if they can be used in the submission.
- Review FDA compliance guidance and standards, testing and other specific requirements needed to claim substantial equivalence to predicate devices.
- Identify and list out the documents, diagrams and other artifacts required by the customer for the submission of the 510(k) Premarket Notification. This will be evaluated by our team for completeness before submission to FDA.
For more information on our compliance assessment services
Quality System Development
It is mandatory for medical device companies to implement a quality system that meets the Quality System Regulation(QSR) imposed by the FDA. The QSR also known as Good Manufacturing Practice (GMP) regulates the design, development, implementation, manufacturing, packaging, labeling, storage and delivery of medical devices.
Netspective’s Fully Functional Quality System
The Netspective Unified Process(NUP) is a completely developed process designed for the development and implementation of safety and life critical systems. The NUP SDLC is designed for systems that need to be implemented using the QSR compliance mandates imposed by the FDA on requirement gathering. design, implementation, testing and maintenance of quality systems.
NUP is a simple to use, online system that contains a ready to use quality system with a wealth of guidance, tools and templates that you can tap into and can be customized for your needs.
Based on your requirements we can have an online quality system up and running for you within a week.
Investigational Device Exemption (IDE)
If the device requires clinical trials to support premarket approval (PMA) or a premarket notification (510k) with the FDA, an IDE needs to be submitted to the FDA. This will allow medical devices to be used in clinical studies without meeting the standards set aside for marketed devices.
Netspective’s FDA consulting services help with the preparation and submission of the Pre-submission application to FDA.
The Netspective FDA consulting team has proven proficiency as subject matter experts in regulatory compliance and can address your specific business needs.Get in Touch with the FDA Team today
Preparation and Submission of the 510(k) application
In addition to preparing and submitting your 510(k) applications, Netspective acts as an FDA follow-up consultant, answering questions from FDA after the submission of your application.
Summary of what we can do for you:
- Prepare and compile all the relevant documents for 510(k) submission once the design, development. Implementation and testing activities are completed.
- Identify missing or additional information. Facilitating document completion.
- Coordinate payment of FDA 510(k) fees.
- Verification of the application and submission to FDA.
- Answer questions from FDA following the submission of the application.
Talk to our team today to see how we can help you.
Final Quality System SOP Development
In addition to having a full fledged QSR compliant quality system, medical device manufacturers also need to establish systems that manage the quality of their products and processes.
Netspective provides you tools that can help you achieve these with ease:
Netspective’s Watchtower, an exception and error management system for your regulated or other mission critical applications can increase your product quality by helping you learn about problems sooner and resolving them faster
Netspective’s Opsfolio provides you with a versatile tool that will let you manage the risks and compliance requirements of your operations portsfolio. Opsfolio provides visualization of network flows, shows relationships and dependencies among operational components that allows IT administrators to handle infrastructure changes effortlessly.
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