Bang Design

Medical Life Sciences Documentation

Medical Life Sciences Creative Technical 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.

Our Services

Strategic Documentation Planning

We collaborate with you to define a clear roadmap, aligning documentation with regulatory requirements and maximizing success probability.

Seamless Regulatory Submissions

We navigate the intricacies of global regulatory landscapes, ensuring your application meets all requirements for a swift and successful approval.

Data-Driven Clinical Evaluation Plans (CEPs)

We utilize advanced analytics to design optimal clinical data collection strategies, demonstrating your device's safety and efficacy.

User-Centered Instructions for Use (IFUs)

Our team crafts clear and intuitive IFUs that empower users for optimal device operation and improved patient outcomes.

Risk Management Files

We utilize advanced analytics to design optimal clinical data collection strategies, demonstrating your device's safety and efficacy.

Technical File Development

We ensure Design History Files (DHFs), Device History Records (DHRs), and Device Master Records (DMRs) are meticulously compiled.

Asset Program Management

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.

Comprehensive Service Documentation

Our team creates service manuals, quick reference guides, and user guides promoting optimal device utilization.

User Guides

Your brand and marketing teams will love our Safety Information and Instruction Manuals with Step-by-Step Instructions.

Maintenance Manuals

We craft detailed maintenance and cleaning manuals, ensuring optimal device function and longevity.

Technical Specifications with Clarity

We provide clear and concise technical specifications, facilitating informed decision-making.

Regulatory Compliance Documentation

We develop Declaration of Conformity documents to seamlessly navigate global regulatory hurdles.

Global Regulatory Expertise

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).
US
Food and Drug Administration (FDA), Premarket Notification (510(k)) or Premarket Approval (PMA)
India

Central Drugs Standard Control Organization (CDSCO).

Canada

Health Canada (HC).

Europe

European Commission (EC) – Medical Devices Regulation (MDR) (2017/745) & Diagnostic Medical Device Regulation (IVDR) (2017/746).

Global

International Medical Device Regulators Forum (IMDRF).

Why Choose
BangDesign?

Unmatched Experience

Our team comprises documentation specialists with a proven track record of success.

Comprehensive Services

We offer a one-stop shop for all your medical device documentation needs.

Global Regulatory Fluency

You get a team that has extensive experience with global regulatory requirements.

Streamlined Efficiency

AI Guided Mood Boards and Storyboards prompted by your product, your market, your customers, and what we observe that your brand stands for.

Subscribe & Get Faster Results

Future Proof Digital Experience

$3599/mo

$

2499

/mo

Per 125 hours

Billed Monthly. Pause and Resume Anytime

What you get

Explore Our Insightful Blog Posts

Design is more than just creating beautiful things; it's a journey full of uncomfortable truths that every designer must face. From navigating

Surgical robots might dominate the headlines, but for many healthcare providers, they're still an aspiration rather than a reality. So, how can

a hand with a glowing wristband

What makes a wearable truly wearable? Dive into the fascinating intersection of health-tech innovations and consumer design, where comfort, precision, and style

a group of people in protective gear working in a factory

In the intricate world of medical device manufacturing, scaling from innovative design to mass production is a journey through strict regulations, security

We believe innovation should stop at nothing.

Something else on your mind?

Scroll to Top