ELSEEMED
Medical Device Support from Design to Product Launch
SERVICES
We provide support to companies operating in the medical device field and to small companies and start-ups aiming to enter this field. Our services include technical guidance for product development, hands-on expertise in standards and documentation, project management, business analysis, regulatory strategy, and training.
DESIGN CONTROL
ISO 13485:2016 & FDA 21 CFR 820.30
A medical device must be safe and meet user needs. Design control is the framework used by medical device companies to address both targets during the development process of the product.
Elseemed helps you create and maintain the design control of your medical device, by defining and preparing major product deliverables such as:
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User Needs
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Design and Development Plan
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Design Inputs (system, subsystem, and module level)
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Product Design
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Design Reviews
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Verification and Validation (plan, protocols, and records)
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Transfer from Development to Production
RISK MANAGEMENT
EN ISO 14971
Risk management is the part of design control that guides you to design a safe device.
Elseemed helps you evaluate and document all risks associated with the use of your device. We can give you support to create and manage the main deliverables related to risk, such as:
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Risk Management Plan
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Risk Analysis
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Risk Evaluation
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Risk Controls
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Evaluation of Overall Risk Acceptability
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FMEAs
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Risk Management Report
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Production and Post-Production Risks
If your device allows connectivity, Elseemed can also help you define cyber attack risks, in accordance with current cybersecurity regulations (which is part of risk management).
Software lifecycle IEC 62304
SOFTWARE
Medical device software development must conform to the IEC 62304 standard "Software life cycle processes"
Elseemed provides full guidance and expertise in this process, helping you in:
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Definition and Documentation of Software Requirements
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Software Development Process
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Software Maintenance Process
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Software Risk Management Process
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Software Configuration Management Process
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Software Problem Resolution Process
Elseemed can evaluate current hardware and software implementation, perform documentation remediation, or help define the software and hardware architecture of your device.
CLINICAL EVALUATION REPORT
MEDDEV 2.7.1 Rev 4
“Clinical evaluation is a methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s Instructions for Use,” MEDDEV 2.7.1 Rev 4, page 6.
Elseemed provides you support in the following activities:
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Stage 0: Scope and Plan
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Stage 1: Identification of Pertinent Data
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Stage 2: Appraisal of Pertinent Data
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Stage 3: Analysis of the Clinical Data
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Stage 4: Clinical Evaluation Report, including PMS/PMCF plan
USABILITY
ISO 13485:2016 & FDA 21 CFR 820.30
The ISO/IEC 62366 standard defines the process manufacturers of medical devices must implement to include usability in the design of their medical products.
Elseemed can support your implementation of this process by:
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Specifying the application of the medical device
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Identifying the device's frequently used functions
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Identifying hazards and hazardous situations related to usability
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Identifying the device's primary operating functions
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Developing the usability specifications
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Preparing the usability validation plan
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Designing and implementing the user interface
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Verifying the user interface design
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Validating the usability of the medical device
BUSINESS
A clear business plan and reimbursement strategy are key points for success. From the beginning, they give direction to your ideas and help you focus on the most important activities.
Defining business strategy and goals is a crucial part of the road to success for a medical device company.
Elseemed can support you in this process by helping you define the major elements:
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Business Plan
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Marketing Analysis
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Marketing Strategy
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Reimbursement Analysis
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Reimbursement Strategy
PROJECT MANAGEMENT
Once business goals and strategy are worked out, you need to detail all activities that will eventually lead you to market your product and to ensure post-market surveillance.
In order to do this, project management is the key point that can ensure you stick to the plan.
Elseemed can provide you PMI certified project management in all phases of your project, from planning, to development, transfer to production, limited launch, and post-market surveillance.
TRAINING
Small companies and start-ups operating in the medical field are mostly busy developing and refining their products, leaving little time to consider process, regulatory, and, sometimes, business issues.
Unfortunately, lack of knowledge of the medical device processes and regulations leads to bad decisions and loss of time.
In order to give you tools to understanding the medical device field and to help you make correct choices from the very beginning, Elseemed provides training, especially tailored to small companies and start-ups.
Elseemed wants to convey the essential elements needed to help you start off on the right foot.
Our major training programs are:
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Basic knowledge of medical device lifecycle for start-ups: from concept to CE mark/FDA approval
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Design control and quality management systems
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Requirement specifications
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Verification and validation
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Risk management (ISO 14971)
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Medical device software lifecycle (IEC 62304)
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Cybersecurity
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Usability
IGNITION TOOLS
Medical device manufacturers need to set up a Quality Management System (QMS) according to international standards, such as ISO 13485.
This also applies to small companies and start-ups that aim to become the legal manufacturer of a medical device.
About 75% of the QMS defines post-market surveillance activities, such as complaint handling, product tracking, etc. As small companies and start-ups are very focused on product development, it is not a good use of resources to start a full implementation of the QMS as a first step.
In our past experience, we have seen that a great benefit comes from considering only a subset of topics defined by the QMS. They are the following:
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Design Control
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Risk Management
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Document Control & Records Management
Elseemed can help you implement such activities that have a concrete impact on medical product development.
Supplier selection and management is a fundamental issue faced by medical device companies. Supplier selection and management is critical to ensuring the performance and safety of your device as well as your business.
Finding the right supplier is not simple and, being a part of the quality management system, Elseemed can help ensure that the appropriate process and control is put in place.
There are some principal steps to follow that are defined in Section 7.4 of the ISO 13485:2016.
Elseemed can offer you support in evaluating, selecting, and managing your future supplier partners in accordance with your quality system.
SUPPLIER MANAGEMENT
Partners
