COMPLETE MEDICAL DEVICE SOLUTIONS
HOW IT WORKS
01
ASSESSMENT
We'll do an initial assessment of your concept or existing system and determine where the gaps are with respect to not just the system but the organization as well. It could be gaps in the quality system, requirements, planning, design, verification/validation, regulatory compliance, and manufacturing process, but we will provide a plan for the purpose of achieving your goals. If your business already has high confidence in the gaps, let's move to step 2.
02
DESIGN
We have experts in medical device development that can provide guidance and approach on various medical device technologies that include but not limited to: surgical robotics, lasers, power electronics, precision sensing, complex systems designs. All these technologies have their specific safety requirements and compliance necessary for a successful submission. Our designs factors in all aspects and phases in the FDA space.
03
VALIDATION
Verification and Validation planning and execution is required not only from regulatory bodies, but also to fully realize a safe system that meets requirements. We can provide planning and execution guidance on this critical phase. Reports will be generated per ISO and IEC standards. We'll work with your team to generate the appropriate documents that goes into your design history file.
MEET
BITCRON MEDICAL
OUR STORY
We started off designing and validating medical devices ranging from class I to class III products in the FDA regulated environment. Many of these companies we worked for were start-ups, which required us to pickup multiple functions required for a successful 510(k) submission. Although engineering was a large component of bringing a medical device to market, there were many other functions on quality, regulatory, verification, validation, manufacturing, and post-market support we needed to focus on for a successful product release.
OUR VISION
We believe our clients should not have to be burdened too heavily with highly specific technologies and requirements from regulatory standards. Our value to our clients is connecting all the pieces and making the medial device fully compliant - which reduces submission risks. Example: a product needing a power-electronics engineer to design a one-time RF therapy subsystem and having in-house quality and regulatory do the complete impact/gap assessment to risks when we can take care of those workflows.
TECHNOLOGY
We have extensive experience in technologies that include but are not limited to RF therapy, aesthetic lasers, surgical robotics, and implantable neuro-stimulators. Our engineers have expertise in wireless telemetry in-body implants interfacing to iOS apps, high-power conversion, lasers, robotic motion control in the medical space. We have additional staff to support our engineers in quality, regulatory, verification, and validation - complete coverage for gaps.
OUR AREAS OF
EXPERTISE:
COMPLIANCE
TECHNOLOGY
VALIDATION
QMS: ISO 13485, FDA 21 CFR 820
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SAFETY: IEC 60601-1 Basic Safety, IEC 60601-1-2 EMC, IEC 62304 Software Lifecycle, IEC 62366 and IEC 60601-1-6 Usability, IEC 60601-1-11 Home Use
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WIRELESS: FCC 47 CFR 15.247, Radio Equipment Directive (RED) ETSI EN 300 328, EN 301 489, Bluetooth SIG
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OTHER: FDA guidance for Cybersecurity, Wireless Coexistence, IP ratings, Biocompatibility, Endotoxins, Labeling, Sterilization
CLINICAL: Cadaver and animal study protocols and planning, IRB, CDRH
SYSTEMS: Robotic motion control specialized for medical applications, multiple wireless subsystem control, medical based laser controller and feedback, medical device capital equipment integrating software and electronics, active implantable devices
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ELECTRONICS: Low current leakage for patient safety, high-power voltage conversion, precision motion/motor control, fiber and flash-lamp laser control, safety-critical circuit protection, high-accuracy analog, FPGA implementation, low-power battery designs, compact flex PCBA
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WIRELESS: Bluetooth LE, Wifi, Cellular, MedRadio
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SOFTWARE/FIRMWARE: Real-time operating systems, iOS iPhone implementation, GUI/UX for medical devices, field buses
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GOALS: Submission for PMA or 510(k), business and compliance synergy, trade-off feasibilities, real-world cost/benefit analysis
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PLANNING: Deliverables, system and interface diagrams, documentation types and structure, milestones/phases
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CLASSIFICATION: Class III to Class I Development life-cycle process, Class C to A Software, Electrical Class I and II
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REQUIREMENTS: Marketing/Clinical, systems, electrical, mechanical, firmware, software, interfaces, manufacturing, testing, and post-market support
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V&V: formative and summative usability, design validation, system, electrical, software, mechanical verification, manufacturing process validation
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DESIGN HISTORY FILE: Checklists, Change Order/release support, IFU
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