MDTK helps you meeting all pre-clinical requirements by a structured risk based approach
Pre-clinical Evaluation
Pre-clinical data should demonstrate (Requirements):
- 1The device has been designed and manufactured in such a way, that it can be used safely and effectively under normal conditions by the defined user or user group for the intended purpose.
- 2An acceptable risk-benefit should be demonstrated by the manufacturer taking into account the need to protect health and safety of patients, users and third parties as well as reflecting the state of the art of the technology applied.
- 3The manufacturer can demonstrate preclinically that design and manufacturing ensure that risks are reduced as far as possible considering chemical, physical, biological properties of the device and clinical application as well as its likely interaction with its packaging and other devices and / or substances.
- 4Preclinical data on stability, performance and safety need to conclude the shelf life of the device.
- 5The label and instructions for use as well as any other marketing material aiming to describe the device and its intended purpose are appropriately done in such a way that patients, users and third parties really understand the use of the device, its handling and any outstanding risks associated with its clinical application.
MDKT can help you meeting requirements for Preclinical development.
We analyse
your development concepts & project risks and assist you in planning appropriate tests. We analyse and
compile your Technical Documentation. Based on a gap analysis we initiate necessary remediation activities.
Pre-Clinical
Evaluation
Requirements
Specification
Requirements management
Within the framework of requirements management, the product requirements of all stakeholders are determined, specified, agreed and documented. This is the initial kick-off of the technical development. Requirements management also includes ensuring traceability, changing requirements and linking to risk management.
Development
Planning &
Development
Development Planning & Development
The development plan is the concrete and detailed implementation of the development process on the product to be developed. It contains the defined goals, milestones and acceptance criteria for the different development phases. Thus, the development plan is the key part of your product development.
Product development is carried out exclusively according to the development plan implementing all necessary regulatory and technical standards.
Design
Transfer
Design Transfer
The Design Transfer is the phase during product development in which the development results are transferred to production. The aim of this process is to ensure that the developed product is reproducible in larger and efficient production.
Verification
& Validation
Verification & Validation
Verification checks whether the developed product complies with the defined requirements while validation checks that it fulfills its intended purpose. All verification and validation activities need to be planned, carried out and documented as an important part of the product development.
Biocompa-
tibility
Biocompatibility
Biocompatibility is the property of all materials which, in direct contact with living tissues, have no negative influence on the patient’s health. Biocompatibility aims to ensure safety and performance for the patient and user through the chemical, biological and physical product properties.
Usability
Usability
Usability is the extent to which a system, product or service can be used by specified users to achieve specified goals with effectiveness, efficiency and satisfaction in a specified context of use.
Feasibility
Study
Feasibility Study
The Feasibility Study is a phase preceding the development process according to ISO 13485. This phase aims to determine and eliminate the technical, economic, legal/regulatory and organizational risks prior to the standardized development phases. This phase is very often neglected or insufficiently carried out because time and effort must be invested initially. But a reliable feasibility study is essential to prevent your development project from failing.
Question/Request form
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