This page is not the official website. Generated by AI, does not constitute any advice. If needed, please click here to visit the corresponding official website.
Trusted by 300+ clients globally, we deliver end-to-end compliance solutions for CE Marking, ISO 13485, MDR, and Authorised Representation across Europe, the UK, and beyond.
Amazon Partner
Bol.com Partner
ISO 9001 & ISO 27001 Certified
From CE Marking to ISO certification and regulatory representation, we guide you through every step of the compliance journey.
Ensure your products meet EU safety, health, and environmental requirements for machinery, electronics, medical devices, and general product safety.
Act as your EU, UK, or Swiss representative to ensure regulatory compliance and market access.
Full support for medical device regulations including MDR, ISO 13485, and Article 10 compliance.
Compliance with EN ISO 12100:2010 and other safety standards for industrial machinery and installations.
Expand your reach with compliance support for Europe, UK, USA, Canada, China, and international markets.
Regulatory pathway guidance, documentation, and compliance for software classified as medical devices.
End-to-end support for ISO 9001 and ISO 13485 quality management system implementation and certification.
Robust CAPA system development and implementation to address non-conformities and improve quality processes.
With over a decade of experience, we’ve helped 300+ companies achieve compliance across diverse industries — from medical technology and machinery to electronics and consumer goods.
Fast Response: Our experts respond within 24 hours to your inquiries.
Regulatory Expertise: Deep knowledge of EU, UK, and international regulations.
Client-Centric: Tailored support for startups, scale-ups, and established enterprises.
Proven Results: 8.7/10 client satisfaction rating based on real feedback.
"Our experience with Certification Experts was pleasant and valuable. The test results during the certification project were comprehensive and detailed and they swiftly offered solutions when there were obstacles."
CTO, Adtrackmedia
"Certification Experts has been helpful, knowledgeable and prompt – even during difficult circumstances surrounding the pandemic. We look forward to working with Certification Experts on future projects."
CTO, Nikon
"Collaboration with the Certification team has been very helpful, professional, fast and flexible. It is always good to have a partner at hand who can help with profound expertise whenever required."
GM Service & Support, New Compliance
"Your expert conducted an internal audit for ISO 13485 at our company. The pre-audit communication was clear and brought valuable expertise. The audit was thorough and effectively pinpointed our areas for improvement."
Operations Manager, Physee
"We have a wonderful experience working with Certification Experts. We are a scale-up company that specialises in doing product developments under a very tight timeline, and the team expertly adjusts to our needs and guides us step by step!"
Quality Assurance Manager, Aria Technologies
"Certification Experts facilitated us to obtain the CE mark for our Cartesian Robot, enabling us to access the European market. Their clear communication and personalized approach made our collaboration a pleasant experience."
Senior QA/QC Engineer, Dot Robot
Guided a medical device startup through full QMS implementation and certification in under 6 months.
Read Case Study →
Enabled a diagnostics company to appoint an EU Authorised Representative and comply with MDR requirements.
Read Case Study →
Supported a machinery manufacturer in achieving CE compliance under Machinery Directive 2006/42/EC.
Read Case Study →CE Marking is a mandatory conformity mark for products sold within the European Economic Area (EEA). It indicates that a product meets EU safety, health, and environmental protection requirements.
Yes, if you are a non-EU manufacturer placing medical devices, machinery, or electronics on the EU market, you are legally required to appoint an EU Authorised Representative.
The timeline varies depending on your current quality system, but typically ranges from 4 to 9 months, including gap analysis, implementation, internal audit, and certification audit.
Yes, we provide full support for UK market access, including UKCA marking guidance and appointment as your UK Responsible Person (UKRP).
Article 10 of the Medical Device Regulation (EU) 2017/745 requires non-EU manufacturers to appoint an EU-based Authorized Representative to act on their behalf for regulatory compliance.
Our experts will reach out within 24 hours to discuss your needs.
Opening hours: Monday to Friday, 08:30 – 17:00
Notice for Buyers: If you are a buyer, the above information is generated by AI collection and does not constitute any advice. If necessary, please visit the corresponding official website.
For Domain Owners: If you are the domain owner and do not want to be included by fobcompany.info, please contact support@fobcompany.info via your corporate email to cancel. We will cancel your inclusion within 3 business days.
如果您是域名所有者 不想被fobcompany.info收录 请用企业邮箱联系support@fobcompany.info 取消收录 我们将在3个工作日取消您的收录
Service Request: If you are other domain and want to be included, please contact support@fobcompany.info
如果您是其他域名合作 也请联系support@fobcompany.info
