Services
Classification of Medical Devices
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Do you need help to classify your medical device? Have you already classified your device but need verification?
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We can help you with this. You can also try our free classification tool as a first step.
Description
Correct classification of a medical device is important as it effects the whole development process, level of scrutiny from the notified body
Topic: Defining the project -scope, specifications, resources, etc.
Time: 1+2+1 days
Max participants: 15
Cost: please contact us
Description
The goal of the boot camp is for a team that is about to embark on a (perhaps years long) development project to think about the consequences of critical choices:
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who is the device for?
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where shall it be used?
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where shall it be launched?
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how much can it cost?
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what resources are needed?
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what regulations do we need to follow?
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is it a one of or will there be a family of similar products?
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Business canvas
These types of questions are often hard/boring/annoying to find answers to.
The boot camp aims to clarify the key points that define the project moving on - and so lessen frustration, save cost, shorten development time, and build a product for the customer.
COURSES
Lean Medical Device Development
Pricing
** Can't see your course here? ** Let us know and we will consider creating one!
Key to winning at any game is understand the rules. Our courses are taught by experienced and practical specialists to help you comply to the rules
REGULATORY ASSISTANCE
MDR/ISO13485 Compliance
UDI/Eudamed
IFUs
Medical Device Manufacturing
Post market Surveillance
You want to focus on value adding activities? Let us help with giving an overview of what you need to do to be in compliance. We can help develop and create your IFU, set up UDI, set up post market surveillance activities.
Templates and Reports
We offer a variety of free templates, ranging from Standard Operating procedures aligned with ISO13485, to Post Market Surveillance checklists, to Classification Reports.
Don't spend time on reinventing the wheel - do what you are good at and we help with the rest.
Post Market Surveillance
With the MDR, Post Market Surveillance is much more stringent than under the MDD.
We help you set up a proper MDR compliant PMS system.
Xybel is creating a SaaS PMS tool which will help companies create a PMS Plan that requires the production of PMS reports (PMSRs) or Periodic Safety Update Reports (PSURs) depending on the device's class.
PMS information is collected in a structured way. PMSR/PSUR data is presented in a clear way ready for use.
Currently seeking champions to partner and beta test - contact us now!
