Medical Device Design and Development

We can support and guide trought all the develoment process. Defining and addressing the User Needs, matching Technical possibilities to Business needs to find best solutions and finally develop a successful product!

We provide support to our clients in getting trought all the product development stages.

From ideation to final market introduction.

We are ISO 13485 certified for Medical Device Design, Development and all related activities.

What Is HFE and Usability? 

There are several terms commonly used to describe the science behind incorporating effective and safe use into a device’s design, including “usability,” “human factors engineering (HFE)” and “ergonomics.” HFE has been added to regulatory requirements to reduce medical device use error, create more operator friendly and intuitive devices and reduce the training costs for both manufacturers and end-users.

From New MDR 2017/745:

“Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art”

IEC 62366 is the reference standard for medical device usability matter and specifies a process for a manufacturer to analyze, describe, develop, and validate the usability of a medical device as it relates to safety:

Part 1 has been updated to include contemporary concepts of usability engineering, while also streamlining the process.

Part 2  provides more detailed descriptions of usability engineering methods that can be applied generally to medical devices.

Why HFE and Usability are important?

• European data: medical errors occur in 8% to 12% of hospitalizations [source: WHO][/source:]
• CE marking of Medical Devices will mandate human factors assessment [Reg. EU 2017/745, from 2020][/Reg.]

Main HFE and Usability Guidance:

ANSI/AAMI HE75 Human Factors Engineering – Design of Medical Devices

• FDA Human Factors Guidance for 510(k) Pre-Market Approval
• ISO 62366 – Application of Usability Engineering to Medical Devices
• ISO 9241 – Ergonomics of Human System Interaction
• EU 2017/745, from 2020
• Applying Human Factors and Usability Engineering to Medical Devices – February 19, 2016

Our Service

Full regulatory compliance to EU and USA requirements- ISO 62366, FDA Guideline

• Risk assessment of human factors
• Wide variety of usability assessment tools

From standard review to user testing, from heuristic analysis to time-and-motion studied

• Design and re-design (device & information for use)
• Usability validation (summative & formative)

Field of Application of HFE expertise and support:

• Medical Devices in All Healthcare Domains
• Medical Device Accessories
• Websites and Mobile Applications
• Health Information Technology
• Documentation and Training
• Anthropometrics and Accessibility
• Signage and Labeling
• Instructions for Use

Team and Partners

We merge our ISO13485 certified expertise in R&D and Medical device development in regulated market with high skilled Engineer and HFE experts from our partner pool like USE-ME-D company to provide extensive support and in depth analysis of your HFE need and requirements.

Reach out to us now and we will be able to support you!

MDR 2017/745 CONSULTING SERVICE

With our team of SMEs and Regulatory experts we provide support to companies in different fields and with different kind of products going through the changes introduced by new MDR.

We will start with a Gap Analysis to assess your current level of compliance and highlight gaps.

Then we will define a proper MDR Transition plan to help you navigate trought the change and reach safe the harbour of MDR compliance.

THE NEW REGULATIONS WILL ENSURE:

• a consistently high level of health and safety protection
for EU citizens using these products
• the free and fair trade of the products throughout the EU
• that EU legislation is adapted to the significant technological and scientific progress occurring in this sector over the last 20 years.

We can help you out and support on hot MDR topics such as: 

• CLASSIFICATION AND CONFORMITY ROUTE
• NOTIFIED BODY SELECTION
• UDI / EUDAMED
• TECHNICAL FILE
• CLINICAL EVALUATION
• PMS PROCESS
• QMS GAP ANALYSIS
• SOFTWARE AS MEDICAL DEVICE
• 3D PRINTED MEDICAL DEVICE
• COMBINATION PRODUCTS

Moreover we will be presents at this event
www.innovabiomed.it

We work for our client in order to get their product on the market efficiently and effectivly.

We provide a full range of regulatory support service, with particular focus to:

• Technical File / Design Dossier
• Design Control
• DHF Design History File
• Risk Management Process
• Clinical Evaluation

From ideation to final market introduction.

We are ISO 13485 certified for Medical Device Design, Development and all related activities.

QMS and Process Validation Support

We support establishment of QMS Quality Management Systems for the Medical Device and Pharma sector in compliance to ISO 13485:2016 and cGMP standard.
 

We provide our experience and support in order to:

• Setting up ISO 13485:2016 QMS
• Prepare for MDSAP Audit
• Perform Supplier and Internal Audit

It is necessary to show that there is full control over all life cycle of a product starting from the ideation, the definition of constraints and specifications, the choice of the design, the production process.

Process Validation is key for reliable manufacturing

We can support in

• Performing IQ/OQ/PQ process validation
• Drafting GAMP5 documentation eg. URS, FDS, HDS, SDS