Expertise You Can Trust
At UserWise, our human factors consultants have worked on a vast variety of medical devices and combination products across numerous medical disciplines, use environments, and user groups. From crafting relevant justifications to creating an accurate model of the use environment for the summative testing, our experienced team can lead you through the entire usability engineering process. Our consultants will develop a customized usability engineering plan for your specific medical device based on the user, use environment, target submission, and complexity of your medical product. We regularly work with all relevant human factors standards, regulations and guidances including those required for CE Mark, FDA approval, and electrical safety testing. Contact us today to learn more.
Regulations & Standards Compliance
UserWise human factors consultants work with our clients to assure compliance to the following regulations, standards, and guidances as they relate to the usability engineering process.
FDA CDRH Guidance: Applying Human Factors Usability to Medical Devices (2016) as well as draft Guidances by CDRH and CDER
MHRA Guidance: Human Factors and Usability Engineering-Guidance for Medical Devices Including Drug-device Combination Products
21 CFR Part 820.30 (c), (d), and (f)
IEC 62366:2007 / A1 (2014)
ISO 14971:2007 & 2012
From prefilled syringes to complex robotic surgery systems, UserWise human factors consultants have a breadth of experience implementing the usability engineering process for medical devices and combination products for small start up through fortune 500 companies, and in between.
Apps for Imaging Systems
Cardiac Mapping Systems
Catheter / Generator Systems
Electrical Stimulation Systems
Flow Diverter Stents
Negative Pressure Wound Therapies
Optometry Diagnostic Devices
Surgical Robotic Systems
Respiratory Ablation Devices
Ultrasound Imaging Systems
User Profiles & Groups
Whether the users of your medical product are Patients with Parkinson’s, Arthritis, or other disease conditions and their Caretakers; are trained healthcare providers with years of education and training; or part of the general population (e.g. smokers); UserWise’s team of expert consultants can partner with your engineers and scientists to ensure your design and risk management efforts consider the specific needs of your users.
Nurses (RN, LVN, Scrub Nurse, Nurse Practicioner)
From highly technical products that are used in healthcare facilities by health care professionals to self-administered products that are used at home, and in between, UserWise human factors consultants have experience considering how different use environments impact the overall risk profile and use of medical products.
Post-op Recovery Suite
Outpatient Surgery Centers
Cardiology (EP, interventional)
Wound Care & Dermatology
Hematology & Chemistry
Vascular (Cardio, Neuro, & Peripheral)