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Medical Life Sciences Documentation
At BangDesign we have a team of industry-leading medical device specialists to cut through this complexity. Leveraging deep regulatory expertise and proven methodologies, we craft clear, concise documentation that expedites regulatory submission and approval, and becomes beautiful product collateral.
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We collaborate with you to define a clear roadmap, aligning documentation with regulatory requirements and maximizing success probability.
We navigate the intricacies of global regulatory landscapes, ensuring your application meets all requirements for a swift and successful approval.
We utilize advanced analytics to design optimal clinical data collection strategies, demonstrating your device’s safety and efficacy.
Our team crafts clear and intuitive IFUs that empower users for optimal device operation and improved patient outcomes.
We utilize advanced analytics to design optimal clinical data collection strategies, demonstrating your device’s safety and efficacy.
We ensure Design History Files (DHFs), Device History Records (DHRs), and Device Master Records (DMRs) are meticulously compiled.
Get a shared or dedicated Asset Program Manager who can coordinate preparation, production and distribution of fresh and revised content to all product programs and managers.
Our team creates service manuals, quick reference guides, and user guides promoting optimal device utilization.
Your brand and marketing teams will love our Safety Information and Instruction Manuals with Step-by-Step Instructions.
We craft detailed maintenance and cleaning manuals, ensuring optimal device function and longevity.
We provide clear and concise technical specifications, facilitating informed decision-making.
We develop Declaration of Conformity documents to seamlessly navigate global regulatory hurdles.
We are well-versed in navigating regulations across various regions. We are also fluent in relevant standards including IEC 60601 series (electrical safety of medical devices), IEC 62366 (medical software), and ISO 14971 (risk management for medical devices).
Food and Drug Administration (FDA), Premarket Notification (510(k)) or Premarket Approval (PMA)
Central Drugs Standard Control Organization (CDSCO).
Health Canada (HC).
European Commission (EC) – Medical Devices Regulation (MDR) (2017/745) & Diagnostic Medical Device Regulation (IVDR) (2017/746).
International Medical Device Regulators Forum (IMDRF).
Our team comprises documentation specialists with a proven track record of success.
We offer a one-stop shop for all your medical device documentation needs.
You get a team that has extensive experience with global regulatory requirements.
AI Guided Mood Boards and Storyboards prompted by your product, your market, your customers, and what we observe that your brand stands for.
$3599/mo
$
/mo
Per 125 hours
Billed Monthly. Pause and Resume Anytime
What you get
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