Our Expertise

Through our work on the design and development of a large variety of medical products, we have gained significant expertise and a deep understanding of

  • The latest regulations, standards, and guidelines, and how to navigate them successfully.

  • A broad variety of medical products and clinical indications.

  • Characteristics of different user populations and use contexts and their impact on use-related safety and usability.

 
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Regulations, standards, and guidelines

Our team possesses an expert understanding of the latest standards, guidelines, and regulations relating to our expert service areas including (but not limited to) the following:

Regulations

  • EU MDR (2017/745)

  • EU GMP Annex 11

  • US FDA 21CFR820

  • US FDA 21CFR11

Standards

  • IEC 62366-1

  • ISO 14971

  • ISO 13485

  • ISO 9001

Guidances

MHRA

  • Human Factors and Usability Engineering

US FDA

  • Clinical Decision Support Software

  • Contents of Premarket Submissions for Device Software Functions

  • Deciding When to Submit a 510(k) for a Change to an Existing Device

  • Design Considerations for Devices Intended for Home Use

  • Presenting Risk Information in Prescription Drug and Medical Device Promotion

  • Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors

  • Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use

  • Applying Human Factors and Usability Engineering to Medical Devices

  • Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications

  • Data Integrity and Compliance with Drug CGMP

  • General Principles of Software Validation

  • Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development

  • List of Highest Priority Devices for Human Factors Review

  • Safety Considerations for Product Design to Minimize Medication Errors Guidance for Industry

 
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Medical products

We have gathered a wealth of experience in the specification, design, and testing of various types of medical products.

Combination products

  • Autoinjectors

  • Pen injectors

  • Prefilled syringes

  • Reconstitution kits

  • Syringe and vial kits

  • Dosing devices

  • Inhalers

In vitro diagnostic solutions

  • Diagnostic tests and instruments

  • Laboratory automation solutions

  • Digital diagnostic solutions

Medical devices

  • Insulin pumps

  • Smart healthcare applications

  • Healthcare applications

  • Medical software solutions

  • Medical imaging devices

  • Cardiac implantable devices

  • Vital signs monitoring

Customer-developed software

  • Warehouse checklist applications

  • Release and delivery process certification systems

  • Drug product release process systems

Configurable off-the-shelf software

  • Data hubs for analytical laboratory devices

Medical products
 
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User populations

Over the years, we have been working with a broad range of user populations. We have a deep understanding of the respective user characteristics that may affect their interactions with the medical product.

Lay users

  • Patients

  • Non-professional caregivers

Healthcare providers

  • Professional caregivers

  • Physicians

  • Surgeons

  • Pediatricians

  • Nurses 

  • Laboratory technicians

  • Medical assistants

  • Paramedics

  • Pharmacists

  • Field service engineers

  • Healthcare managers

  • Qualified persons

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Use contexts

We understand the relevant characteristics of clinical and non-clinical use contexts, and are able to systematically take them into account during the design and development process, so that the resulting solutions are accommodating of the conditions that could impact use safety, effectiveness, and usability.

Home and public environments

  • Indoors (e.g., bedroom, livingroom)

  • Outdoors (e.g., bus stop, shopping mall)

Healthcare environments

  • Operating theaters

  • Medical clinics

  • Neonatal intensive care units

  • Doctors’ offices

  • Emergency vehicles

Research and manufacturing environments

  • Laboratories

  • Quality control

 
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Clinical indications

Our team has been working on solutions for facilitating the diagnosis and treatment of numerous clinical indications. This enables us to understand the challenges, risks, and opportunities in areas including (but not limited to):

  • Asthma

  • Chronic Heart Failure

  • Coronary Artery Disease

  • Growth Hormone Deficiency

  • Chronic Obstructive Lung Disease (COPD)

  • Dry Eye Disease

  • Diabetes

  • Fertility Treatments

  • Heart Failure

  • Hypertension

  • Multiple Sclerosis

  • Retinopathy of Prematurity 

  • Traumatic Injuries

  • Wet Age-Related Macular Degeneration

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