Regulatory Requirements for Products
Get assistance in clarification of approval requirements to ensure that your product complies with the law and can be labelled and marketed correctly.
Different product requirements on different marketsAs manufacturer of equipment for different markets around the World, you will encounter a considerable number of requirements for approvals and marketing. The intended use of the product as well as technical structure matter. Is it for industrial use? Or medical use? Is it a wireless product? These factors are determining for the many, often different requirements.
Why choose FORCE Technology for technical guidance for the approval plan?FORCE Technology is notified body on several directives and regulations. We do accredited certification according to ISO 17065, and we are National Certification Body under IECEE CB Scheme. We participate to a great extent in standardization work and have thus participated in the writing of the requirements in many cases. This means that we have first-hand knowledge on the regulatory conditions. When receiving an approval plan from FORCE, you can rely on it!
FORCE Technology has many years of experience as Denmark’s largest all-in-one test house and supplier of approval of electronic products. We have some of the world’s best specialist with extensive knowledge. With consideration for your needs, they focus on you achieving a successful result and the necessary approvals.
Can FORCE Technology act as external Regulatory Affairs (R/A) partner?
Yes, it is one of FORCE Technology’s key services to investigate the regulatory conditions for your specific product on specific markets. We call it ”Approval Management”, since there is more to it than just identifying requirements. It also comprises management of the approval as project manager, including own and third party test laboratories, and assisting in compilation of approval documentation, the so-called technical documentation or technical construction file. It is important for us to ensure that the labelling and the attestation of conformity as well as all other parts of the documentation basis are performed correctly without flaws and deficiencies.
As notified body we know what we are talking about, and you have the possibility to strengthen the validity of the documentation with a notified body certificate (see Certification).
Can FORCE Technology assist us in identification of approval requirements for global market access?
Yes, as National Certification Body (NCB) within CB Scheme, we have access to a global family of business partners, who all help each other with national requirements. And as CB Scheme laboratory, you can be certain that a report from FORCE provides you with the expected, national market access. Some laboratories make reports in CB Scheme format without the reports actually being genuine, certified CB Scheme reports.
One-stop-shop for product compliance
As Denmark’s largest all-in-one test house, we offer to take care of the entire product approval process.
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We are a world-leading test house for hearing aids and the only Danish company doing certification of hearing clinics.
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