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User manual template machinery with video

€497.00

document
Microsoft Word Template and Video Course

Product Details
You want to import, trade and/or sell your machinery on the European market? You want to do this according to the legal requirements to avoid problems at customs or to decrease liability? We have developed a video course that instructs you on how to create a compliant user manual.

  • Gain confidence when selling your machinery
  • Create a compliant manual with this video course and template
  • All relevant regulations processed in one template

The IFU Medical Devices template is an MS Word template, that contains all mandatory elements to create your own IFU for a medical device. You can use the template to create IF that complies with the CE marking requirements, the Medical Device Regulation/Medical Device Directive, the EN 82079 standard for User Instructions and the ANSI Z535.6 for Safety Messages.

The package contains:

  • User Manual Template for Machinery as MS Word Document
  • 84 Explainer Videos with almost 2 hours of videos explaining how to use the template (worth: € 619,-). A must when you have no experience with the MD or IEC 82079 yet.
  • Adobe InDesign Template (well-designed InDesign Template (worth: € 181,-)
  • CE Marking Checklist
  • IEC 82079 Checklist
  • eBook: How to Create Compliant Instructions
  • Bonus: ANSI & ISO safety signs
  • Bonus: Video on the online publication
  • Bonus: Declaration of conformity template

Compliance
The user instructions function is to explain to the user how a product can be used safely and correctly. The user manual informs the user about risks that still persist, despite the adoption of measures for inherent safe design, safeguarding, and complementary protection. Failure to warn the user properly can make the manufacturer liable in case of any accidents.

With this template, you assure compliance with:

  • CE marking compliance
  • Machinery Directive compliance
  • IEC 82079 compliance
  • ISO 3864 and ANSI Z535.6 compliance

Money-Back Guarantee
All our templates have a 14-day, no-reason-required guarantee. So, if you are not satisfied for any reason, just let us know and we’ll refund your money. As we believe that our product really helps you to create better instructions, we are convinced it will not come to that.

Information Supply

We notify you if there are regulatory changes pertaining to your product

Technical File

We ensure the availability of the technical file in case of requests from authorities

Legal point of contact

We represent you on your behalf for all legal issues pertaining to your product

EU/UK Market Access

You gain access to the EU/UK market, no matter where your business is located

Authorised Representative

We register as your official point of contact for market surveillance authorities

CE/UKCA Marking

Trust us as your partner to verify the compliance of your products

Expert Consulting

With over 25 years’ industry experience, our team can provide expert guidance
on every aspect of product compliance.

  • Product Compliance
  • Authority letter (NVWA, NoBo, ILT and BPT)
  • Authorised Representative
  • Product Testing
  • Seller/buyer problem resolution on CE marking
  • Advise on Product Legislation
  • User Information
  • Route to compliance
  • Engineering Review
  • Training
  • Risk Assessment
Training

We offer custom training programs led by experts, bringing your team up to
speed with important safety processes and regulations related to your markets.

  • Product Compliance
  • CE Marking
  • Machine / Robotics Safety
  • UL/CSA
  • Safexpert
User Information Review

Make sure your manuals, labelling and packaging are fully compliant with your
chosen markets. From writing to reviewing materials, we’ve got you covered.

  • Checklists
  • Product labelling
  • Templates
  • Drafting Manuals
  • Machine plate
Risk Assessment

We help you eliminate risks more efficiently, protect your customers and your business. Unsure whether you’ve done something correctly? We can provide a full risk assessment evaluation.

  • Machine / Electronics / Toys / Medical / PPE / GPS
  • EN-ISO 12100
  • Safexpert Risk Assessment software (TÜV-certified)
  • Review of existing Risk Assessment
  • Templates
Route to compliance

We create a clear and practical compliance roadmap for you in any market. Get expert guidance on cost/time efficiency of certification for accessing multiple markets.

  • Determining product legislation
  • Set up test procedure (in-house/accredited testing)
  • Strategy on Global Market Access
  • Technical File Checklist
Testing and Inspection

Wherever you’re located, we offer a wide range of expert testing and inspection capabilities, both in house and via our global network of affiliated partners and testing laboratories.

  • EMC, Low Voltage, Radio, Medical, Toys, and PPE
  • On-site or digital inspections
  • Notified Bodies
  • Accredited testing laboratories
Engineering Review

We review your designs and assist you through the prototype phase to ensure critical safety standards are met.

  • Design Review
  • Co-engineering
  • Consultancy
  • Risk Assessment
Technical File

Every manufacturer requires a technical file to reach compliance. We support, compile and review these technical documents for you.

  • Declaration of Conformity
  • User Information (manual/labelling/packaging)
  • Risk Assessment
  • Technical schemes and drawings
  • Templates
Authorised Representative

We provide Authorised Representation (AR) for businesses and e-commerce companies located outside the EU/UK – allowing access to those markets by registering us as your legal partner.

  • EU/UK market access
  • Verification of CE/UKCA
  • Marking
  • Contact point for authorities
  • Technical File
  • Bypass importers
  • Registration
Compliance

Enter any market, no matter the marking or industry. From CE marking and UL to CCC, we offer complete certification guidance and expert services tailored to your unique situation.

  • Consultancy
  • Route to compliance
  • Testing
  • On-site inspections
  • Design Review
  • Technical File Review
  • Risk Assessment
  • Training