Global Regulatory Compliance, Testing, and Authorized Representation:
Accelerate Your Expansion with a Reliable Compliance Process
Regulatory compliance, starting with CE marking, is indispensable for global expansion. We work with you from the planning stage to prevent customs holds or recalls caused by unexpected non-compliance. We offer comprehensive support, from performing product risk assessments and identifying potential hazards, to researching standards, testing actual products, and creating technical documentation and instruction manuals. Crestec enables the safe and smooth expansion of global business through a balance of design and information.
3 Reasons Clients Continue to Choose Us
Risk assessments and regulatory research from the early stages of development greatly reduce the risk of rework
Correcting issues related to non-compliance with standards after a design is complete costs time and money. Crestec partners with you from the product planning and conceptual stages, conducting risk assessments and researching international laws and regulations based on global safety standards and your internal company standards. By providing early feedback on your designs, we aim to help you prevent rework and smoothly and effectively enter the market.
Product Safety Compliance SupportOn-site verification at your factory eliminates the need to move large equipment
We specialize in handling industrial machinery that is difficult to transport to testing facilities. Our engineers can come to your factory to perform on-site machine safety, electrical safety, and EMC inspections, and issue conformity evaluation reports in English. Performing verification on-site reduces transportation costs and minimizes the risk of damaging machinery.
Machinery Safety and EMC TestingOne-stop support for technical files and European Authorized Representative services that eliminate barriers to European expansion
In addition to providing support compiling the massive technical file required for CE marking, Crestec’s Netherlands subsidiary can act as the European Authorized Representative to handle regulatory communication on behalf of clients who don’t have a local European corporate entity. For our Japanese clients, we offer one-stop assistance in Japanese, from document creation to post-export risk management.
European Authorized Representative ServiceService Lineup
Product Safety Compliance Support
We deliver end-to-end compliance support for even the most complex regulations, aligned with your product development process
We provide comprehensive support in line with your development process, covering evaluation testing required for CE marking and global regulatory standards, product risk assessments, and drafting and compilation of technical documentation.
- Risk Assessment Support
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We assist with risk assessments conducted in accordance with international standards, including ISO 12100 (General principles for design – Risk assessment and risk reduction), as well as the local safety standards of each country. We identify hazards according to product limitations and perform risk estimation and evaluation.
We offer total support with risk reduction strategies that incorporate “reasonably foreseeable misuse.” In addition to exploring design-based solutions (inherently safer design) and guard installation (protective devices), we handle the entire process of drafting specific safety messages (warning labels and cautionary text) that convey any residual risks on the product itself and in instruction manuals.
We also offer consultation on risk assessment reviews and safety messaging for products currently on the market.
We thoroughly evaluate instruction manuals and warning labels against the applicable regulations and safety standards of relevant countries to verify whether residual risks have been effectively reduced. We identify excess or missing information and deliver strategic improvement plans designed to protect users while helping mitigate legal risks for your businesses.Additionally, you can contact us for consultation related to the clarity and usability of instruction manuals based on IEC/IEEE 82079-1, the international standard on the preparation of information for the use of products.
Manual Consulting
- Researching each country’s laws, regulations, and standards
- We cover European directives like CE marking, as well as a broad spectrum of regulations and standards for countries around the world. Besides selecting regulations and directives according to product category and researching applicable standards, we also investigate local laws and unique standards that are easily overlooked. Based on our findings, we support you in appropriately incorporating compliance requirements into your designs and specifications. Furthermore, we identify essential description requirements and provide guidance for their inclusion in user manuals and nameplates.
- Support for drafting and compiling technical documentation
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Crestec offers support for drafting and compiling technical documentation* required by the laws and regulations of each country. We do it all, from providing lists of necessary documents to confirming the accuracy and completeness of their contents. For CE marking, we use our original STED (Summary of Technical Documents) file to verify satisfactory compliance without directly revealing highly confidential information such as design drawings. Furthermore, our STED data can be used as history management documentation when making changes to CE technical documents due to design modifications or component changes after distribution in the EU.
*Technical documentation: Refers to a complete set of documents used to prove conformity with applicable laws and regulations.
Machinery Safety and EMC Testing
Backing Global Expansion from the Technical Side
We provide engineer-focused safety design consulting combined directly with on-site testing on the actual products.
- Safety design consulting
- We assist with compliance for the EU Machinery Regulation (MR) and international ISO/EN standards by reviewing drawings and conducting on-site evaluations of actual products, providing a detailed explanation of the engineering intent required by the standards, including the background and the rationale behind identified hazards, based on technical grounds. Rather than merely assessing pass/fail status, we collaborate with your engineering team to determine practical technical solutions that enable clear understanding, offering continuous support to help accumulate design know-how for subsequent models.
- On-site compliance verification
- To reduce the transportation costs, labor, and damage risks associated with moving large industrial machinery, we offer on-site verification. Our specialized engineers bring measurement and evaluation equipment directly to your plant or installation site. We conduct machinery and electrical safety assessments to evaluate risks such as electric shock and fire, as well as EMC testing to check electromagnetic emission suppression and immunity. Upon completion, we provide an English verification report suitable for direct submission to overseas authorities and export destinations.
- Specialization in industrial machinery and equipment
- Our verification services are specialized in industrial machinery and equipment, including machine tools, semiconductor production systems, and manufacturing lines. Testing is handled by specialized engineers familiar with site-specific installation setups and operational conditions (excluding consumer electronics). By evaluating your equipment with a comprehensive grasp of industry practices and actual operating procedures, we can offer realistic and flexible schedule adjustments, and deliver robust, practical support for compliance with international safety standards.
European Authorized Representative Service
Support for Legal Obligations Through Our Netherlands Office and Local Contact in Japan
Crestec’s Netherlands office acts as a European Authorized Representative to fulfill mandatory economic operator liaison obligations on behalf of non-EU manufacturers placing products on the European market.
- Streamlined EU market entry without a local subsidiary
- Our Dutch subsidiary, Crestec Europe B.V., has over 13 years of experience as an “Economic Operator (EU Authorized Representative).” Crestec Europe B.V. works on your behalf to promptly respond to inquiries from local EU authorities and markets, and properly stores your latest technical documentation. When expanding into Europe, this allows you to rapidly build a safe and legally compliant distribution network while significantly reducing the cost, time, and burden of establishing your own local subsidiary or liaison office.
- Complete support in Japanese
- Crestec’s Japanese entity serves as the sole liaison for all practical consultations and any compliance inquiries raised by local authorities in Europe. You do not need to correspond directly with European representatives in English or local languages. Through our seamless domestic support handled entirely in Japanese, your team can maintain efficient EU regulatory compliance without being hindered by time zone delays or linguistic barriers.
Service Flow
STEP
Consultation
We conduct an in-depth review of your requirements, including product overviews, technical specifications, planned shipping timelines, and target export countries or regions. We examine your existing documentation and development status to gain a clear understanding of your current challenges and budget.
STEP
Planning and Estimate
Based on the content of our initial consultation, we propose a comprehensive schedule and optimal implementation plan tailored to your safety compliance needs. After defining the exact scope of work and team roles, we prepare a detailed cost estimate.
STEP
Regulatory Research
We identify applicable laws, regulations, and standards based on your target export markets. Determining the mandatory statement requirements for user manuals and nameplates during the planning phase helps to prevent the need for reworking designs in subsequent processes.
STEP
Risk Assessment Support
We perform hazard identification, risk estimation, and risk evaluation in accordance with international safety standards. After examining risk reduction solutions including inherently safer design and protective devices, we formulate the supporting rationale for reflecting residual risks as safety warnings in instruction manuals.
STEP
Evaluation Testing and Technical Solutions
We conduct actual on-site conformity testing for industrial machinery at your factory or designated facility. Prior to testing, we perform drawing checks and structural verification to provide you with feedback on technical countermeasures such as design modifications or component selection concerns that are necessary for compliance.
STEP
Instruction Manual Production and Technical Document Preparation
Based on the results of the risk assessment (residual risks), we create instruction manuals, nameplates, and packaging that comply with the applicable laws, regulations, and standards. Throughout this process, we systematically collect and compile various drawings and test reports into the technical documentation (technical files) that will serve as evidence of conformity.
STEP
Declaration of Conformity, Shipment and Authorized Representative Support
We assist with the creation of your Declaration of Conformity and propose and check the proper content and placement of markings on your products. Crestec’s subsidiary in the Netherlands serves as your European Authorized Representative for products shipped within the EU, providing end-to-end support for local regulatory compliance through our Japanese point of contact even after market entry.
Frequently Asked Questions
- Can we request safety testing or certification for general household appliances?
- Our testing and consulting is primarily focused on industrial machinery. Although we do not perform testing on consumer electronics, we can refer you to reliable partner organizations. Don’t hesitate to contact us first for guidance.
- How can we export to the EU (Europe) if we don’t have a local branch or entity there?
- Our Netherlands office can act as your European Authorized Representative to handle point-of-contact operations on your behalf. Our Japanese entity serves as your domestic point-of-contact, ensuring that processes flow smoothly completely in Japanese without having to worry about time zone or language barriers.
- At which point in the development process should we consult with Crestec?
- We strongly recommend contacting us during the planning and design stages in order to prevent the need to rework designs. Working together early in the development process allows us to conduct necessary regulatory research and identify mandatory descriptions that must be included in instruction manuals, thereby avoiding the risk of last-minute modifications and supporting smooth entry into the market.
- Can you provide risk assessment support if we can’t do it in-house?
- Yes. Our specialized department can execute risk assessments based on international standards such as ISO 12100. We support everything from hazard identification to risk evaluation, and provide concrete proposals for safety warnings and warning labels based on the residual risks presented in our findings.
- Can Crestec fully compile and prepare the technical file required for CE marking on our behalf?
- We provide comprehensive support for structuring and drafting technical files, organizing existing data, and handling English translations. To get started, you’ll need to provide the core technical data that only your company possesses, such as design blueprints or calculation sheets. From there, we will take charge of systematically compiling your assets into the technical file required for proof of compliance, while also creating test reports and instruction manuals. Contact us for a consultation on role distribution and workflows.
Service Information and Inquiries
Contact us for help navigating the challenges of regulatory compliance for international and domestic product sales and shipping.
*This service provides support for researching, structuring, evaluating, and documenting compliance with product safety regulations and standards.
It does not constitute a guarantee of final compliance approval under national laws and regulations, certification attainment, decisions by regulatory authorities, or permission for commercial distribution.
Actual support service contents differ based on factors including product specifications, target destinations, distribution models, governing laws, and mandatory certifications.
You must independently confirm and fulfill the specific requirements based on up-to-date regulations and standard procedures.