DESIGN FOR THE EU
We are the solution.
From confusing obligations to a streamlined process.
Our Solution
Identification and analysis of applicable laws, directives, and regulations.
Subsequent, structured standards research.
Deriving the specific requirements for manufacturers, distributors, customers, and products.
Comprehensive risk analysis according to relevant regulations.
Full management and support of the CE conformity procedure and/or certification strategy throughout the entire product development process: from the product idea to CE marking or EC approval.
Development, implementation, maintenance, and audit of the required or desired quality management systems (ISO 9001, EN ISO 13485, KBA initial assessment, ISO 14001, ISO 45001, ISO 50001, CSR, LkSG, CSDDD, CBAM, EUDR, etc.)
Monitoring of your production on-site, worldwide.
- Strukturierte Normenrecherche
- Analyse von Gesetzen & Paragraphen
- Anwendung von EU-Richtlinien
- Umfassende Risikoanalyse
- Begleitung zur CE-Kennzeichnung
- Aufbau von QM-Systemen (ISO 9001)
Your partner for the EU market
Our Services
We support producers, manufacturers, importers, and distributors in complying with their legal requirements. With many years of practical expertise, we are your independent expert, lecturer, auditor, and mediator.
Our network of engineers, lawyers, and translators offers you fast and efficient strategies and solutions, whether you are seeking relief from CE conformity, need to update your quality management system, or require an authorized EU representative.
You receive our comprehensive support throughout the entire product lifecycle, from the product idea through certification, production, distribution, and disposal.
We work with you and for you, precisely according to your needs and requirements.
Our Expertise
- A holistic, appropriate, and cost-effective approach from A to Z.
- Many years of expertise in communicating with authorities (customs, market surveillance) and consumer protection agencies (Stiftung Warentest, the press, etc.).
- We build trust in your company as a manufacturer, trading partner, or supplier, as well as confidence in your products.
- We work worldwide, with your on-site development team and with your suppliers.
- We offer our 24/7 emergency service for new and existing customers.
Harald Guoth
Founder & Owner
With over 30 years of practical experience at Germany’s leading manufacturers and trading companies, the namesake of the Ingenieurbüro Guoth (Guoth Engineering Office) is dedicated to offering his expertise to a broad clientele.
The skilful and consistent fulfilment of regulatory requirements has consistently provided his employers and clients with competitive advantages.
On the one hand, the trusting collaboration with us made it possible to bring innovative products to market in compliance with legal requirements.
On the other hand, compliant documents have opened the doors to critical major customers.
our clients
Manufacturers and importers
Buyers & Distributors
Educational Institutions
Organizations
Our services
Product Safety / Compliance / Approval Processes
We cover the entire product development process to ensure a smooth market entry. This includes, among other things:
- Product Classification & Certification Strategy: We define the right path for your product. We identify the applicable requirements and determine how compliance with them will be achieved.
- Required Documentation: Support with risk analyses, operating instructions, product labeling, and declarations of conformity. This creates robust records that meet the requirements of completeness and adequacy.
- Usability (UX): Tests to determine the user-friendliness of your products. This is required by law, improves customer reviews, and facilitates sales.
- Type Approvals: We support EC type approvals until approval is granted and subsequent requirements are met.
- Examples of product groups: Machinery, toys, low-voltage products, construction products, motor vehicles, battery- or radio-operated products, clothing, furniture, tools, PPE, batteries, AI products, medical devices, bicycles, and e-bikes.
Proof of suitability as a manufacturer / quality management systems
- Requirements assessment: We find the right quality management system for your company (ISO 9001, KBA initial assessment, ISO 13485, etc.). In addition to your own requirements, the requirements arising from your products are recorded and incorporated into an integrated management system.
- Implementation: Creation, audit, and revision of your quality management system until certification readiness and recertification.
- Certification support: We support you throughout the entire certification process.
Assumption of manufacturer obligations / Authorized representative
- Authorized EU representative: Appointing an authorized representative for the EU is mandatory for products from third countries. In other cases, authorization may be advantageous. We act as your official representative in the EU in all matters, completely relieving you and your customers of any burden.
- Legally compliant distribution: Our network secures your distribution throughout the EU.
- Protection of trade secrets: We protect your interests and confidential data.
Production Quality and Suitability Testing
- CoP-Testing: Worldwide testing of the quality and conformity of your production (=CoP).
- Audits: We audit your products and producers, including environmental protection, CSR, and the German Supply Chain Act (LkSG).
- Additional Services: Support with product recalls, trade fair participation, and sales.
Training courses and seminars
Training: We offer lectures and seminars on our services covering relevant EU directives, EU regulations, manufacturer obligations, CE compliance, product safety, and quality management. Our seminars are specifically aimed at responsible persons, CE and QM representatives, designers, and purchasers.
The process to your success
Analysis & Strategy
We begin with an in-depth analysis of your product, target markets, and applicable EU directives and national laws. Based on this, we identify the applicable EN standards and develop a customized and efficient certification strategy.
Documentation
We prepare, review, and complete all required documentation, such as risk analyses, technical documentation, operating instructions, and declarations of conformity.
Testing & Validation
In cooperation with our network of accredited testing laboratories, we coordinate all necessary tests and validations for your product to ensure unequivocal proof of conformity.
Certification & Market Entry
We support you through the entire process of certification and CE marking, ensuring that your product meets all the requirements for a smooth and legally compliant market entry in the EU.
Quality Assurance and CoP (Conformity of Production)
We support CoP audits, both internally and externally. We also monitor the market for complaints, accidents, recalls, and misuse of your product groups. This ensures that manufacturers' obligations are fully met and verified.
Expertise that counts
Years of experience
We stand for balanced risk minimization to achieve ambitious corporate goals. Our services include corporate organization, supplier management, product development, purchasing, sales, and customer satisfaction.
In addition to your objectives, we consider all relevant European regulations – for example:
- Product Safety & Consumer Protection: General Product Safety Regulation (GPSR, EU 2023/988), Toy Safety Directive 2009/48/EC.
- Machinery & Technology: Machinery Directive 2006/42/EC and Regulation (EU) 2023/1230, Low Voltage Directive (2014/35/EU), EMC Directive (2014/30/EU), Radio Equipment Directive 2014/53/EU, Medical Devices Regulation (EU 2017/745).
- Vehicles & Mobility: Regulation (EU) 168/2013 for motorized two-wheelers.
- Norms & Standards: EN 71, EN 60335, EN 62841, EN 4210, EN 15194, EN 9001.
Thus, our customers achieve legally compliant, pragmatic fulfillment of their obligations with us.
Your benefits
Fast time to market
We accelerate your processes and ensure a smooth market launch.
Legally compliant documentation
Save time and money
Reduce your workload and focus on your core business.
Risk minimization
Protect yourself from fines, product recalls, and liability claims.
Expert network
Benefit from our access to experts and accredited testing laboratories.
Added value & reputation
Stories of success
Automotive industry
CE marking for an e-bike manufacturer
Consumer goods
Development of a quality management system (ISO 9001)
Toy industry
EU representation for US manufacturer
Taking on all manufacturer obligations as an authorized representative to ensure a smooth market entry into the EU.
FAQ
We already have a CE test certificate from TÜV; is that sufficient?
No. A test certificate or a TÜV certificate can be helpful, but it does not replace the legally required EU Declaration of Conformity (DoC). This DoC is necessary to be able to affix the CE marking. Accredited testing bodies do not issue DoCs. We can assist you with this: We will review the applicable directives, prepare the necessary documentation, draft the declaration of conformity, and support you throughout the entire conformity assessment process and beyond.
I have a declaration of conformity; does that mean my product is market-ready?
No. In addition to a declaration of conformity, some directives require that your company has an appropriate quality management system in place.
If you already have a quality management system, we would be happy to review it to determine whether it meets the requirements for your new product.
We would also be pleased to assist you in implementing an appropriate quality management system.
Does the Ingenieurbüro Guoth (Guoth Engineering Office) also work for companies from non-EU member states?
Is the Ingenieurbüro Guoth (Guoth Engineering Office) accredited or sworn?
Where does Ingenieurbüro Guoth (Guoth Engineering Office) offer its services?
Our employees generally work from home, unless otherwise agreed or necessary due to the circumstances.
In the greater Dortmund-Düsseldorf-Cologne-Aachen-Luxembourg area, we have the necessary infrastructure (libraries, universities, testing laboratories) to be able to take on new topics at any time.
We work locally in North Rhine-Westphalia (NRW) and worldwide to manage your projects.
Is Ingenieurbüro Guoth (Guoth Engineering Office) the right partner for us?
It’s always worth inquiring; Ingenieurbüro Guoth can refer you to suitable companies if necessary.
We are the right partner when good advice needs to be put into practice.
Ingenieurbüro Guoth primarily focuses on organizational and technical market access in the EU. This includes the development of global production facilities and products, as well as the establishment of sales organizations in the EU.
Ingenieurbüro Guoth also develops global market access to non-EU markets. For this purpose, domestic production facilities and sales offices can be established.
As part of its compliance policy, Ingenieurbüro Guoth declines the following services:
a) Trading in goods and products of any kind.
b) Political work, lobbying on behalf of third parties.
c) Activities that could create a conflict of interest with existing clients.
free contact
Kontakt aufnehmen
E-Mail: info@guoth.eu