Customized seminars & training tailored to your company and your products
- Many years of experience have taught us to bring the complex relationships to the point and to structure the learning content adapted to the audience
- Understanding of essential topics from the legal bases is essential in construction, production and sales
- Sensitivity to the topics facilitates decision-making processes and communication with suppliers and customers alike.
- Knowledge of the relevant legal bases strengthens the position of your employees and enables them to make targeted demands and sound statements to customers and suppliers.
You simply apply the CE mark and sign the Declaration of Conformity, worry-free
Willy Lebherz
Director & founder of easyCE GmbH
Declaration of conformity done!
Receive your CE declaration of conformity ready for signature.
Risk assessment completed!
CE mandatory risk analysis conducted.
Relevant directives & standards applied!
Your product evaluated against relevant directives and standards.
Technical documentation created!
Receive a pragmatic, user-friendly operating manual.
CE mark attached!
Simply affix the CE mark and you're done.
FAQ
Typical learning objectives and course of a seminar at your location
The participants strengthen their position towards suppliers, customers and employees through what they have learned. They are safer in the daily application of the legal bases and can formulate targeted demands
on suppliers and sound statements to customers. Typically, we see a group of participants of approx. 10 employees from the fields of construction, electronics, marketing/sales, QM/QS and management. The event will be held on your premises. The seminar will usually take one day (depending on the content, the seminar may take longer).
Example seminar: EC conformity assessment procedures involving the applicable harmonised standards
1. Participants recognize the aim of the legal bases for manufacturers and operators from the presented and determined requirements from EC directives, national laws and harmonized standards,
2. Participants get an overview of the applicable directives, laws and harmonized standards,
3. Participants recognize the special requirement for manufacturers with regard to product safety of their products for the entire service life of the products,
4. Participants recognize that the conformity assessment procedure requires all areas of a manufacturer
5. Participants get an overview of the applicable standards and the applicable conformity assessment procedure
6. Participants recognize the connection of requirements from standards and guidelines, the need for proof of compliance with the requirements and the resulting declaration of conformity (conformity) of the products with the requirements,
7. Recognize the importance of an internal factory production control according to the specifications of standards and directives and regulations.
These important questions will be answered in the seminar
We provide you with an overview of all EC directives and regulations. We explain the scope and objective of directives and harmonised standards. We also explain the legal context.
In particular, the distinction between directive and law, product safety and product liability, EC declaration of conformity and installation declaration and CE marking. You will get an overview of the hierarchy of European standards. The presumption of conformity in conjunction with harmonised standards and legal basis and standards research. You will learn how to evaluate the requirements. We then develop the requirements from Annex I of MRL 2006/42/EC and a selection of harmonized standards (EN). How are product limits defined? How is the risk assessment carried out? What are the stages of risk mitigation measures? How are residual risks documented? What is the process of calculations, tests, stress tests, procedures, documentation and evidence? How do you handle warnings and notices? When is a declaration of conformity and when is a declaration of performance? What is the content of the declarations and what is the effect?
Hundreds of companies trust easyCE
With easyCE, product compliance is really 'easy'
Approach to CE marking
Type and manner of support
Scope of support
Contact during project processing
Find the easiest way to obtain the CE mark
Abbreviated process for CE derived directly from CE
All-inclusive or modular – whatever you prefer
Personal contact with experts who take your wishes into account
other CE service providers
Often lacking in sound judgement and unnecessarily complicated
Mostly flexible but often bureaucratic
Mostly flexible in terms of support scope
Mostly personal contact
CE Software
Follows standardised process; special circumstances not taken into account
Double burden for you: software management + no support during processing
Only according to software scope and purchased modules
No contact
You want support that lightens your workload and doesn't create more work.
Reference Projects
CE marking of laboratory machines developed in-house
In the course of an upcoming ISO 45001 occupational health and safety audit, easyCE supported a laboratory technology manufacturer in ensuring CE conformity for its internally used validation machines for medical equipment. Our specialists conducted a comprehensive assessment of occupational health and safety aspects and integrated these into the CE documentation. Particular attention was paid to safe operation by laboratory staff and the documentation of risk assessments that meet both CE and ISO 45001 requirements.
Takes into account, among others: 2006/42/EU, 2014/35/EU, 2014/30/EU, 2011/65/EU EN ISO 12100, EN 60204-1
CE marking for a laboratory robot
In the course of an upcoming ISO 45001 occupational health and safety audit, easyCE supported a medical technology manufacturer in achieving CE conformity for its coagulation robot—a specialized laboratory machine for the automated performance of coagulation cycles for testing purposes. Our specialists conducted a comprehensive assessment of occupational health and safety aspects and integrated these into the CE documentation. Particular attention was paid to the safe handling of electrosurgical components and the documentation of risk assessments that meet both CE and ISO 45001 requirements.
Takes into account, among others: 2006/42/EU, 2014/35/EU, 2014/30/EU, 2011/65/EU, EN ISO 12100, EN 60204-1, etc.
CE marking and consulting for laboratory equipment
In the context of an upcoming ISO 45001 certification, easyCE supported a medical technology manufacturer with the CE documentation for a specialized testing and calibration machine for insufflators in the laboratory sector. Our specialists developed integrated documentation that covers both the CE requirements and the occupational health and safety aspects according to ISO 45001. Particular attention was paid to the safety requirements for handling various hose systems and connections, which can vary depending on the insufflator model.
Takes into account, among others: 2006/42/EU, 2014/35/EU, 2014/30/EU, 2011/65/EU, EN ISO 12100, EN 60204-1 etc.
CE marking for electrical equipment in medical laboratories
As part of the ISO 45001 certification preparation process, easyCE supported a manufacturer of electrical laboratory equipment in the correct classification and CE conformity of its products. Our experts carried out a precise analysis to distinguish between medical devices and electrical equipment in order to ensure correct classification in terms of occupational health and safety. This clarity was crucial for the ISO 45001 requirements regarding hazard identification and risk assessment in the workplace. Successful documentation and conformity assessment enabled the customer to operate its laboratory equipment in full compliance with occupational health and safety guidelines and to pass the ISO audit without any objections.
Takes into account, among others: EN 55032, EN 55035, EN 60335-1 etc.
CE marking for test station for low-pressure units
In the run-up to an ISO 45001 occupational health and safety audit, easyCE supported an industrial company in compiling CE documentation for an internal test bench for low-pressure units in accordance with occupational health and safety regulations. Our experts first analyzed the regulatory classification of the test bench and were able to prove through precise measurements that the Pressure Equipment Directive was not applicable. This clarification was crucial for the correct risk assessment within the framework of the ISO 45001 management system. The CE documentation subsequently created took particular account of occupational health and safety aspects such as operational safety and emergency procedures. This enabled the customer not only to demonstrate CE conformity, but also to pass its ISO 45001 certification without any deviations in the area of work equipment.
Takes into account, among others: 2006/42/EG, EN ISO 12100, EN 60204-1, EN ISO 4414, EN ISO 13849-1 etc.
Learn more about our project references and success stories
Get CE-marking done in 3 simple steps
Step 1
Request expert opinion
Ask for our expert opinion free of charge and find out what is necessary for the CE marking of your product. Be prepared to describe your product in broad terms.
Step 2
Receive our offer
If your product is subject to CE marking, we offer you our support with the CE marking and all accompanying measures. We will be happy to explain necessary steps on the phone.
Step 3
We get it done
When you place an order, you will be assigned your own personal CE expert who will carry out your CE marking and accompany you throughout the entire process. Your expert will also be at your side after the CE marking has been successfully completed.
Get CE-marking done, worry-free
Trust the experts of product safety and conformity
Willy Lebherz - Founder and Managing Director of easyCE
- Expert in product safety and conformity since 1995
- Recipient of the "Medal of the Order of Merit of the Federal Republic of Germany", awarded in 1983 by the then Federal President Carl Carstens
- Master of measurement and control technology
- Captain (ret.), Project Officer for Technical Logistics in the Army Material Office and Chief of the Telecommunications Repair Company
easyCE is a digital, dynamic engineering office with a focus on product safety and product conformity - especially CE-marking. We support manufacturers, operators and dealers in designing products safely and offering them on the market in compliance. We are a "full-service provider" and can take over the entire conformity assessment process for you if you wish. To do this, we support you in carrying out risk assessments, researching standards, product analyses, developing suitable safety precautions, preparing user-friendly technical documentation, coordinating tests and all other accompanying measures. easyCE was founded in southern Germany, but is now active globally.
We know what you need to do to get CE-marking done, worry-free.