Get your Usability Engineering / HF Strategy quickly and reliably
Check out our starter plans.
How Usability Engineering Starter works with us:
01. Starter-Workshop
In a joint workshop we assess the current status of your Usability / Human Factors Engineering.
02. Identify Requirements
Based on the results of the workshop we identify the regulatory and market-specific Usability / Human Factors Engineering requirements for your product(s).
03. Define Strategy
We develop a Usability Engineering / HF strategy that covers all requirements. This will provide you with clear instructions on how to achieve regulatory compliance.
Pick the plan that supports your goals:
Usability Engineering Starter
What it contains:
Starter Workshop: In a joint workshop we assess the current status of your Usability / Human Factors Engineering. We have a look at:
- The medical device
- Your user group
- Your use environment
- Your intended markets
- Existing preparatory work including risk management
- Your internal processes and SOPs
Identify Requirements: Based on the results of the workshop we identify the regulatory and market-specific Usability / Human Factors Engineering requirements for your product(s).
Usability Engineering Strategy: We develop a Usability Engineering / HF strategy that covers all requirements. This will provide you with clear instructions on how to achieve regulatory compliance.
Your Invest:
3.000€
Make it Plus
The whole Usability Engineering Starter plan plus:
Our Premium Template set for Usability & Human Factors Engineering: In this package, you will receive all the necessary templates for regulatory compliance in the field of usability and human factors engineering.
Your Invest:
+500€
Certified for excellence
Benefits of having a precise Usability Engineering / HF strategy
Know exactly how to get market clearance
With a Usability Engineering / HF strategy in place, you have a clear roadmap to navigate the regulatory requirements necessary to bring your product(s) to market. This enables you to effectively plan your tasks & timelines well in advance.
Speed up your time to market
A precise Usability Engineering / HF strategy allows you to shorten development cycles by mitigating unforeseen regulatory issues. This, in turn, enables you to bring your product(s) to the market more quickly.
You can prioritize the target markets
Allocate the right budget
Why we are the perfect partner for your Usability
Engineering / HF strategy?
We are specialized in medical devices and IVDs: QM system according to ISO 13485, TÜV-certified Medical Device Experts and equipment perfectly tailored to medical devices and IVDs – with us you have a partner who knows his stuff!
We supported already over 300 medical devices / IVDs: Through our efficient process, we have expertly guided these products to market clearance, ensuring a secure and user-friendly experience for our consumers.
If you need an execution partner for your strategy – we are fully equipped: We can support you in every need regarding the Documentation or Usability of medical devices / IVDs. From specialized labs to conduct your formative/summative evaluation/HF validation to our location in the USA that aids in FDA approval – we’ve got you covered.
What do our customers say about us?
„Custom Medical has been helpful in depth. It’s given us a lot of advices for creating the relevant usability engineering file in addition, to have a nice user interface. To having someone available via videoconference or email can help us with usability engineering evaluation related questions of what the best practices are and how they are applied in the study. And I think that’s Custom Medical apart from anyone else.“
„It was easy to work with Custom Medical. Their structured approach to projects resulted in the successful completion of our project. We would recommend Custom Medical to companies looking for a reliable and structured partner in usability engineering, especially medical device companies facing the issue of summative evaluation.“
„Working with Custom Medical was very relaxed. […] I would recommend Custom Medical to anyone who does not have enough usability engineering resources in-house. The advantage of Custom Medical is that they not only take care of product validation, but also help improve the UX design of a product.“
Ludwig Wildner | Chief Technology Officer @PreciPoint
Let’s get started!
