Medical Device Development
Perficio Product Development can assist you in the development of your medical device across all the required disciplines, or in individual aspects of development.
For Research and Development, Perficio Product Development can assist in the identification and prioritisation of specific tasks to fast track commercial development opportunities. We can also conduct Research and Development for customers requiring assistance with new ideas or concepts.
Research and Development.
Planning Phase
- Project definition and scope
- Project planning
- Analysis of current product or new product concept and identification of development priorities
Design Phase
- Detailed system, subsystem, and module specifications
- Detailed functional analysis, architecture definition, and physical definition
- Detailed engineering design (electrical, mechanical, and software)
- Specialty engineering (risk, reliability, safety, maintainability, and ILS work)
- Detailed design description
- Risk Management (FMEA/FMECA, FTA, Hazards Analysis)
- Analysis of current product or new product concept and identification of development priorities
- Configuration management
- Definition of the Design History File
Verification & Validation Phase
- V&V plans, protocols, reports, and summaries (for each requirement level)
- Conduct of V&V activities
Regulatory Submission Preparation
- Development of technical files and other regulatory data as required by your regulatory strategy
Market Release Phase
- Analysis of product performance
- Assistance with implementation and use of FRACAS and CAPA Systems
- Assistance with product failure analysis
- Risk Management (analysis and update of product risks and hazards)
Risk Management
Risk management is a mandated regulatory requirement and an essential task that underpins all medical device activities, including the development of a medical device. Companies who do not have appropriate systems for analysis and management of hazards and risks will waste time in the preparation of inadequate risk analysis, and will not benefit from the information that can be gained from an efficient risk analysis process.
In order to manage the risks associated with a device, a risk management process needs to identify the medical device hazards, to estimate and evaluate the risk of each hazard occurring, to determine the root cause of the hazard, to define required mitigating actions, to track the mitigations and monitor the effectiveness of the mitigations. The complexity of the risk analysis will be dictated by the medical device classification.
ISO 14971 is the most widely accepted medical device risk analysis standard. Perficio Product Development use this standard along with military standards (MIL-STD-882E) and associated risk analysis tools (FTA, FMECA) to analyse the risks created during the design, manufacturing, testing or use of a medical device.
Perficio Product Development has extensive experience with medical device risk management activities, from initial concept through to commercialisation and can therefore assist your designers with this vital and mandatory aspect of your development program. Completing your products risk analysis with Perficio Product Development will provide you with a regulatory compliant analysis that will also enable you to define specifications for critical materials, manufacturing processes, test criteria and instructions for the use of your medical device.
Manufacturing your Medical Device
Manufacture of your medical device must be conducted in accordance with the regulatory requirements of your target market. Most commonly and depending on it’s risk class, your device will need to be manufactured in accordance with the requirements of the harmonised standards of ISO 13485:2003 Medical devices - Quality management System- Requirements for regulatory purposes and 21 CFR 820 Quality System Regulation (USA).
Perficio Product Development is able to provide you with guidance and examples of how to establish, qualify and control your product ‘s manufacturing and test system in a compliant and safe manner.
The objectives of establishing a well qualified and controlled manufacturing system match the objectives of establishing an efficient and economical manufacturing system. This is because high yield and low field returns should be a natural consequence of effectively established medical device manufacturing system. The establishment of an effective medical device manufacturing system can only be achieved if the preceding product development activities are conducted in the appropriate manner.