FDA 21 CFR Part 820 and ISO 13485:2016 requires medical devices to meet regulations and be fully documented. Being unfamiliar with project planning, device documentation, regulations or having limited staff can hinder your medical device project. These short comings can result in missing corporate milestones that may impacting funding. Qualitas can manage your medical device project for guidance on the regulations / FDA consensus standards, provide a complete documentation package, and lead your organization through the hurdles of getting a device to market.
Qualitas has expertise in managing medical device projects from concept to market entry. We can work side-by-side with your team to manage the necessary device milestones in order to quickly and efficiently meet compliance objectives and corporate milestones. Whether you need us to manage a specific aspect of the project or the entire project, we are here to assist and our goal is to promote an environment that expedites your development and compliance needs. Qualitas can assist your development needs with the following:
- Guiding medical device design through the necessary regulatory hurdles and challenges
- Conducting a gap analysis for an existing device, documenting gaps, and providing guidance on path forward for compliance and ease of manufacturing.
- Mentor team on Quality Management System requirements, medical device files, usability requirements, and compliance standards / regulations
- Review device for FDA classification and determination on the applicable consensus standards for a device.
- Providing inputs on what needs to be accomplished to meet compliance standards and assist in interpreting the standards
- Conducting device compliance reviews for medical devices FDA Class I – III products. Including combination devices and electro-mechanical software controlled devices.
- Reviewing and documenting device and process risk per ISO 14971
- Generating technical documentation to meet milestones
- Reviewing and assisting with labeling (e.g. device labels, instructions for use, quick reference guides, etc.).
- Documenting and setting up Unique Device Identification (UDI)
- Acting as independent reviewer and subject matter expert during design reviews
- Helping to select and evaluate industry specific credible suppliers for contract manufacturing, sterilization, certification testing, biocompatibility testing, etc.
- Managing suppliers and act as a contact point to streamline supplier communication
- Meeting with suppliers for device compliance reviews and to drive timelines
- Assisting with the design transition to manufacturing
Having a partner that has been through the challenges of device designs and overcoming the hurdles of compliance is invaluable. Selecting the right partner to manage your project can save your company time, money, and speed to market entry.
Contact us today to drive your medical device development forward!