A copy of instructions and other information supplied for the safe use of the product. A significant stage of the CE marking process is to produce technical documentation for the product to provide evidence of conformity for the relevant legislation. Product(s) Building code. As mentioned, the technical file is described in Annex II and III of the MDR 2017/745.. Below I will try to explain to you what is expected in each of the sections. Start learning. Technical Specifications. The outputs include data and standard operating procedures to protocols, a variety of reports, and supporting business content. Learn about support options and licensing for VMware vSphere Access free training and technical documentation | VMware CA. Green Certification. Similar Technical Documents. Here are some of the services on offer: If you would like further information on how we can help, then please contact the technical team on 01564 792349. The Foundation Certification focuses on knowledge of the field. Technical documentation in software engineering is the umbrella term that encompasses all written documents and materials dealing with software product development. The Society produces multiple live, one-hour, webinars each month on technical communication topics ranging from accessibility to user experience design. Member news; Announcements; News. The Technical File must be available as soon as the product is placed on the European market, whatever its geographical origin is. Technical Documentation composition. FSC Certification Certification FSC. Certificate Course In Structured Writing For Technical Documentation (30 Hours) The field of technical writing has come a long way from writing clearly and concisely using a keyboard into a new world of structured writing and content management. Have questions, need specifics? General requirements, such as design principles, comfort and effectiveness, design and fitting systems, etc. This analysis must be included in the technical documentation. Part of every conformity assessment procedure of medical devices is the composing of the Technical Documentation. Full detailed drawings, with any calculations, test results, etc., providing proof of the products conformity with the essential health and safety requirements of the applicable Directive/Regulation, Copy of the risk assessment, which has documented the identification and mitigation of applicable risks and hazards. Learn how to plan and author technical documents. Read more Producing clear technical documentation for your products or your software requires the … Login. All software development products, whether created by a small team or a large corporation, require some related documentation. The technical documentation for face masks according to the PPE 2016/425 must contain the following elements: General description of the product and scope of application. 01.110 Technical product documentation Including rules for preparation of user guides, manuals, product specifications, etc. Some of the requirements can be common across the Directives and Regulations, but to give you a good idea of what is required we have used the technical documentation requirements given in Annex VII of the Machinery Directive as an example. A significant stage of the CE marking process is to produce technical documentation for the product to provide evidence of conformity for the relevant legislation. If the company complies, they will receive their PEFC chain of custody certificate. Certification shows employers that you have the writing ability, specialized training, and knowledge to synthesize technical information in a specialized area. The process of acquiring a certification can be as useful as the certification itself since often, it means taking a course (or multiple courses) that train you in the minutia of the position you’re hoping to get. BSI offers technical documentation review through our CE-Excellence services; you will be assigned a dedicated Scheme Manager to work with you throughout your product certification ToDo. Canada United States Europe. The new Medical Device Regulation (MDR) has arrived. Type. Product Documentation (Technical File) - example. BSI has a strong commitment to providing the most experienced and efficient routes to market. 1-877-486-9273. CfPIE is pleased to offer document management training and DMCP certification opportunities to industry personnel responsible for compliantly managing documentation that is produced across a diverse spectrum of product development activities. Get in touch with specialised assistance services, Get advice on EU rules that apply to your business / solve problems with a public authority, Licensing and selling intellectual property, Infringement of intellectual property rights, Taxes on parent companies and subsidiaries, Request a review of a public procurement procedure, E-commerce, distance and off-premises selling, Package travel and linked travel arrangements, Technical documentation and EU declaration of conformity, Classification, labelling and packaging of chemicals, conformity assessment for protective equipment, conformity assessment for 3D printing and 3D printed products to be used in a medical context, applicable legislation for leave-on hand cleaners and hand disinfectants (gel, solution), national contact points for medical devices, EN 149:2009 Respiratory protective devices – Filtering half masks to protect against particles - Requirements, testing, marking (commonly referred to as 'FFP masks'), EN 14683:2019 EN Medical face masks - Requirements and test method, EN 166:2001 Personal eye-protection – Specifications, EN 14126:2003 Protective clothing - Performance requirements and tests methods for protective clothing against infective agents, EN 14605:2009 Protective clothing against liquid chemicals - performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only, EN 13795-1:2019 Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns, EN 13795-2:2019 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods, EN 455-1:2000 Medical gloves for single use - Part 1: Requirements and testing for freedom from holes (MDD), EN 455-2:2015 Medical gloves for single use - Part 2: Requirements and testing for physical properties (MMD), EN 455-3:2015 Medical gloves for single use - Part 3: Requirements and testing for biological evaluation (MDD), EN 455-4:2009 EN Medical gloves for single use - Part 4: Requirements and testing for shelf life determination (MDD), EN ISO 374-5:2017 Protective gloves against dangerous chemicals and micro-organisms - Part 5: Terminology and performance requirements for micro-organisms risks, EN ISO 13688:2013 Protective clothing - General requirements, EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, The ‘Blue Guide’ on the implementation of EU products rules, Publications Office of the European Union, ensure the technical documentation is made available to the market surveillance authorities (should they request to see it), keep the technical documentation for 10 years, your name and address, or those of any authorised representatives, identification of the product, for example, the product's serial number, the name(s) and address(es) of the facilities involved in the design and manufacture of the product, a statement of relevant regulations to which the product complies, identification of technical standards with which compliance is claimed, your name and full business address or that of your authorised representative, the product's serial number, model or type identification, a statement, stating you take full responsibility, means of identification of product allowing traceability – this can include an image, the details of the notified body which carried out the, the relevant legislation with which the product complies, as well as any, supplementary information (if applicable). Help and support. The Technical File must contain all information that is necessary to demonstrate the conformity of the product to the applicable requirements. Technical Writing One and Technical Writing Two consist of two parts: pre-class lessons; in-class lessons with a facilitator and other students; The pre-class lessons provide a solid educational experience, which the in-class lessons enhance. Ask questions and learn from others in the technical community. If you are new to API documentation, this is a great place to start. Obviously the above list is not exhaustive of what can be kept in the technical file, other relevant information may also be added. Documentation center - Uniboard EN This instructor-led, live training (online or onsite) is aimed at persons who wish to write technical documentation but lack the experience of a trained technical writer. ; our... home > product documentation Including rules for preparation of user guides,,... 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