CE Marking: How to Create a Technical File
“REVEALED: The Exact Step By Step System To Correctly Create a Technical File.
Get Your Product Approvals To Sell Into The European Market So You Save Time, Save Money, And Grow Your Company’s Profits”
First Let Me Ask You These Questions. Answer As honestly as you can.
- Has your Technical File been sitting on the shelf gathering dust since you first completed it?
- Have there been any component or design changes since you applied the CE Marking?
- Have you not applied the latest standards since you did it once when you first shipped?
- Have you been depending on your subcontractors or test lab keeping you up to date on the latest relevant requirements?
- If you have never done this before, do you keep putting off getting started, because you are just plain overwhelmed?
If you answered “YES” to any of these questions, then you are like most people involved in exporting to Europe. Don’t put your company at risk by:
- Being an easy target for large fines
- Having your product withdrawn from the market because of outdated documentation and standards
- Incurring large sales delays due to confusion about your product versus a look alike counterfeit
- Damaging the company brand or reputation
Our regulatory engineers at Phoenix Technical Group have spent over thirty years researching, writing, testing and producing Technical Files for 100’s of clients exporting to or based in the European Union. Our clients range from Fortune 100 companies to semi-conductor equipment manufacturers to producers of DVD players and hair curling irons. We have advised Brussels Directorates, National Governments, and trained EU enforcement officers. Our systematic approach works for our clients and it can work for you if you follow our detailed instructions and tutorials. Even if you have never done this before!
If You Have Ever Done Anything with CE Marking, Then You Already Know…
- That there are very specific pieces of information and documentation that go into the required Technical File.
- EU authorities are trained to look for exact information.
- No central places to go to get all of your questions answered, and even if you can get an answer for your question, it may not be correct. EU sources only give general information and don’t answer your questions.
- Plus, the rules and regulations of the EU are CONSTANTLY changing.
The Problems Today:
Many thousands of companies face enforcement action in the EU from:
- Enforcement officer random request for a Technical File
- Competitor complaint
- Consumer compliant
- Investigation and re-test of a product
- Investigation of an alleged incident, injury or death
YOUR RESULTS COULD BE ONE OR MORE OF THESE:
- A stiff fine for Failure to produce a Technical File within the required 10 days The easiest offence to prove –
- Shipment held at point of entry (add on customs storage charges at 100’s per day) for lack of correct documentation
- Product rejected at point of entry
- Enforced Product Recall
- Voluntary Product Recall
- Punitive Fines
- Individual Civil Actions Under Consumer Legislation (in EU law a consumer only needs to prove ‘injury’ to succeed)
- An unauthorized change or part substitution
- Hazardous counterfeit copies of your product have been confused with your product
- Use “How to Create a Technical File” to update your Technical File with the latest information and requirements – $997
- Hire a consultant for a week at $2,400 a day ($12,000)
- OR Wait for EU Enforcement authorities to contact you ($10,000 → unlimited)
OUR TRIED AND PROVEN SYSTEM
Easy to follow instructions, video, audio & templates all in one package
The CE Marking Essentials program takes you step by step, and is the first complete program to take you from knowing possibly nothing about CE marking to having your technical file created correctly. We even provide you with tabs, Section Dividers, Table of Contents, and complete description of what information goes in each section.
Click to view larger image of course contents.
Inside this Course, you’ll discover:
Module 1: Introduction and Purpose
- Overview of Technical Structure
- Copyright & information Statements
- Recall Plans
- Lifetime Access to Technical Library
Module 2: Training Materials for You & Your Team
- What’s in the Package and How You Use It
- What is Required
- Integration with QMS & Configuration
- Management System
Module 3: The Technical File
- Why We Create It
- History and Background
- When You Start
- How You Begin
Module 4: Legal Appointments
- How You Choose an Authorised Representative
- Who is the Responsible Person
- Creating a Partner Relationship
- EU Law
- National Regulations
- EU Languages
Module 5: Technical File Outline
- How to Select Directives
- How to Create a Declaration of Conformity
- Standards – EMC, General Safety Directive,
- LVD, Machinery, Medical Device, RTTE & Toys
Module 6: Defining Your Product
- Detailed Descriptions & Explanations
- Regulatory Issues, Solutions, Hazards
- Electrical Issues
- Machinery Issues
Module 7: Anti-Counterfeiting Measures
- Design Calculations
- Instructions & Manufacturing Drawings
- Critical Components
Module 8: Testing to Demonstrate Compliance
- Testing and Test Reports
Module 9: Testing to Demonstrate Compliance
- Demonstrating Production Control
- Maintenance and Updating
- Change Logs
Try CE Marking Essentials: How To Create A Technical File Today –
CE Essentials: How to Create a Technical File is designed for companies of all sizes and provides detailed guidance step-by-step on how to create the technical file for your product or product family – even those companies who use multiple Teams to complete the technical files.
The course includes the “How to Create” Document, Templates and Bonus Materials plus instructional videos and unlimited access to the Technical Library – and lifetime free updates.
Unlimited Access to the CE Essentials: How to Create a Technical File Training Course for
CE Essentials: How to Create a Technical File
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No travel expense, no gimmicks, no surprises… Just simple solutions for common engineering problems!