The technical documentation for medical devices bundles all documents important for the manufacturer and end user concerning the product, the decisions made, the individual components and the entire creation. It is the key to a functional and safe medical device. From the very first requirements and throughout the entire development of the medical device, holistic documentation ensures traceability and reliability right from the start. As a result of the increased product safety that this entails, detailed technical documentation is mandatory for manufacturers on the part of the regulatory authorities and medical technology standards.
However, good technical documentation of medical devices goes beyond the mere obligation to comply with standards: In addition to the regulatory and normative benefits, the manufacturer himself also benefits from precise documentation of the relevant steps. On the one hand, it serves as reassurance to avoid errors with problematic consequences – and also to minimize risks in the case of further development – and is also the hub for usability and risk management to ensure the health and safety of patients at all times.
Quality Characteristics of Good Technical Documentations:
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It traces the development of the product from the idea to market surveillance
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It is clearly formulated and gets to the heart of the information needed
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It is structured and linked in a meaningful way
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It is easy to update or transferable for similar products
The high demands on technical documentation for medical devices have increased in recent years, and yet it is worthwhile to create it not only to comply with the standards. Because in the process, it often recedes into the background that it is significantly goal-oriented for the success of the medical devices.
Essential Contents of a Technical Documentation for Medical Devices:
General product information
Specifications
Technical specifications
History of the product
Risk Management
Our Service in the Field of Technical Documentation of Medical Devices:
We create documents that are required as part of the overall technical documentation – with and for our customers. We often work directly in the customer's quality management system and check documents for completeness (review). In addition, we advise on the content and structure of the documents so that the overall package makes sense, benefiting from our best practice examples. If desired, we support the creation of templates that the customer can use for future products. We also offer solutions in the area of building product platforms so that documents for different products do not have to be created anew each time. In doing so, we focus entirely on the customer's needs: Whether start ups that still have to overcome the normative hurdles or large companies that want to expand already existing documents – we support you with technical documentation for medical devices.
Our interdisciplinary team is field tested thanks to our own medical device development and brings a wealth of experience to the table – from technical documentation to testing, we cover the entire product development cycle. The resulting open view of the relevant topics helps us to document all important details to ensure optimal tracking in the product life cycle of medical devices.
Our Technical Documentation Services at a Glance:
We create comprehensive technical documentation and optimize existing documents for design input, design output, design verification and design validation as required. Listed below is an excerpt of our services:
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Technical reports (e.g. root cause analysis) and test protocols
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Technical drawings and parts lists (BOM)
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Tolerance analyses
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Traceability matrix
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FMEA and Risk analyses
With our wide range of experience, we provide our customers with comprehensive consulting and design services, for example in the following areas:
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Checking existing documents for completeness
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Identification of optimization potentials
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Advise on the development of platform documentation
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Setting up an FMEA including moderation
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Transfer of the contents from the design verification to the Notified Body opinion documentation.
Our service allows our customers to focus on their core tasks and provides them with a customized solution for professionally prepared technical documentation of their medical devices.
FAQ Technical Documentation
The technical documentation of medical devices is a compilation of all relevant documents that are created throughout the entire product life cycle. It not only pursues the goal of fulfilling the manufacturer's obligations to provide evidence to legal requirements and organizations – in the case of medical devices, in particular the MDR (Medical Device Regulation) and ISO 13485:2016 or the specifications of the FDA – but also contains documents that are made available to the customer, such as the operating instructions.
For us, technical documentation for medical devices is not just an accumulation of documents whose creation is necessary due to specifications, but a great opportunity to collect a company's knowledge and know how and make it meaningfully retrievable.
The manufacturers of medical devices must prepare the technical documentation in order to be able to submit it to the notified bodies. Furthermore, it is also used as a red thread within the scope of audits. However, it is also a guide to the product itself, which makes it possible to comprehensibly record the entire history of the product's development and thus answer current and future questions about the product.
At invenio, we not only provide support for technical documentation, but also develop products according to ISO 13485. Based on this experience, we are convinced that documents should not become a stumbling block in development, but should accompany and complement it in order to achieve the goal of a safe and robust product.
The technical documentation for medical devices is very diverse and its content varies according to the requirements of the country of approval. However, the core content is general information on the product – for example, its purpose and intended use – the product specifications (e.g., parts list, design calculations), technical information on the product (e.g., design drawings, materials and biocompatibility), and specifications on the development and quality assurance of the product from production to use by the end customer. Another essential component is the documents that contain the risk management of the product and thus provide the foundation for the safe manufacture and use of the product.
Because of this enormous diversity, the best documents for us are those that are linked to the rest of the technical documentation in a robust and traceable way, so that they fit optimally into their environment. In this way, the technical documentation becomes a structured collection of linked documents that can be reused as far as possible in the development of new products in the platform mindset.
ISO 13485:2016 introduced the medical device file. Here, documents are prescribed that the technical documentation of medical device types/groups must contain:
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General description of the product including intended purpose, labeling and instructions for use
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Product specification
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Specifications for the product life cycle up to and including distribution (manufacture, packaging, storage, distribution)
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Procedures for measurement and monitoring
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Requirements for installation and maintenance
Not only these essential documents provided by the standard, but the entire technical documentation must be comprehensible and traceable even years after a product has been placed on the market. We therefore demand that the documents we produce can be traced at any time and by any person from the relevant group of readers.
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