Usability engineering- also known as human factors engineering- is focused on designing medical...
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BUSINESS PLAN WRITING
Many of our consultants have been Board level executives in their own right and have immense experience of presenting business cases in a succinct and compelling manner that attracts the attention of busy investors and other important stakeholders. We can collate and present information you already have and where necessary fill gaps that remain
MARKET ACCESS STRATEGY
We provide full consultancy support for the development and implementation of your market access strategy. We combine an understanding of the global pricing and reimbursement systems with access to payers, clinicians and patients for medical device products, at all stages of development and in all key geographic markets.
MARKET ASSESSMENT
We can evaluate market opportunities using both primary and secondary data. We use our extensive international network of clinicians, procurement managers and other healthcare professionals to identify an appropriate cohort of interviewees and then ask the right questions to accurately assess and analyses he opportunity.
PROCESS VALIDATION
We have experts who can validate processes including manufacturing processes such as heat treatment, sterilization process validation, software validation by following the related standards requirements and defining definite protocols for validation so that the process remains in compliance and deliver accurate results.
PRODUCT DEVELOPMENT
Our team can contribute to product development as per the regulatory requirements for design and development by following the regulatory requirements pertaining to these. With our help, you can transform your idea to actual product.
PROCESS DEVELOPMENT
We can put out knowledge and expertise related to manufacturing processes to your aid and help to optimize the manufacturing processes, maintain quality and efficiency of the processes at your facility.
RISK ASSESSMENT
Our team can help you to identify all potential hazard and associated events that can cause harm related to both the products and processes and also provide an insight on how to avoid and/or reduce the possibility and impact of those associated harms.
COMPLAINT HANDLING
In case of any complaints and any unfortunate incident, we can help you on complaint and vigilance case handling, suggest possible corrective and preventive actions, documentation and submission to authorities.
MEDICAL DEVICE FILES DEVELOPMENT
Our team of experts can help you to develop related files for your medical devices as per regulatory requirements such as ISO 13485/MDD/MDR, address associated non-conformities and help to clear cases.
MANGEMENT SYSTEM DEVELOPMENT
We can help in developing, documenting and implementing management systems as per ISO 13485, 9001, 14001, ISO 45000, SA8000 and also handle audits of relevant notified bodies.
TRAINING
Our team of experts can provide customized trainings sessions for your personnel, share our knowledge and experience and help you to grow.
CLINICAL SIMULATION TESTING
Before a medical device hits the market, its performance has to be verified to assure that the medical device is capable of achieving its stated medical purpose. Our technical team can help you to verify the device performance by clinical simulation testing which will be simulation of the actual device usage.
SHELF-LIFE STUDIES
Our team of experts can provide customized trainings sessions for your personnel, share our knowledge and experience and help you to grow.
BIOLOGICAL ASSESSMENT
We can help to assess the medical device biologically to ensure safe interaction between the device and biological substances such as cells, tissues, blood. This assessment will be done based on the specific device type and as per the latest applicable standard requirements.
CLINICAL EVALUATION STUDIES
Our experts can help you to gather sufficient safety and performance data by performing clinical evaluation studies by following suitable routes and as per latest regulatory requirements (MEDDEV, MDCG).
PRODUCT SAFETY AND PERFORMANCE TESTING
Our team can help to device proper strategy to carry out carry out safety and performance tests as per the relevant and latest regulatory and standard requirements.
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Usability Engineering For Medical Devices
Ethylene Oxide: Validation Process Overview
ETO is a colorless gas that is flammable and explosive. The four essential parameters (operatio...
Key Requirements of MDR
On April 5, 2017, the EU adopted the Medical Device Regulation, replacing the two existing dire...