As a manufacturer of equipment for various markets around the world, you will be faced with a large number of requirements for approvals and marketing. We can help with the approval, so the market access is guaranteed.
There may be significant savings, both in terms of time and money, by having the right strategy for approval. If, for example, there are multiple product types, several intended uses and functions or perhaps a product portfolio that is continuously evolving, it is a good idea to make a thorough plan. Maybe several product variants can be approved by testing just one type. Or maybe your’s products cannot be transported to a testing facility and therefore must be approved in a different way. In any case, an appropriate regulatory approval procedure must be followed for each part of the world in which the product will be marketed.
We provide an overview of approval requirements and ensures progress in the process. Our specialists have many years of experience and knowledge about approval management and know of the authorising bodies and procedures. We prepare approval plans and conduct detailed test planning, so you get an accurate checklist for your preparation prior to the test.
We review your product and the documentation with you and disclose any necessary changes and updates. We guide your product through all the tests, and offer advice and guidance if your product fails a test. We also help you prepare the approval documentation, the ‘technical dossier’, and ensure that all requirements for the included documentation are met, and that all the correct information has been written on the label. In addition, we provide templates for the declaration of conformity, and other relevant items available as well as help to fill them out. Once all documentation is in place, we help you obtain certificates and markings.
With FORCE Technology by your side, you avoid making mistakes, and you will quickly and safely reach your end-goal with the necessary approvals in the various markets.
If changes happen in the form of new legislation, a new version of a standard, or an amendment to an authorisation system, we can also help you determine whether that will have any significant impact on your already-approved product.
With professional approval management advice you will gain a number of strategic advantages:
- Quick access to the market
- A full overview of the licensing requirements for your product
- Ensure compliance with regulatory requirements
- Reliable authentication documentation that facilitates the approval procedure
We have many years of experience with approval of electronic and electrical products. We have some of the industry’s most experienced and knowledgeable testing experts who will listen to your needs and ensure that you end up with the necessary approvals.
Our Approval Management team can advise you on the following:
- Approval strategy
- Definition of intended use and classification
- Approval plan
- Detailed test planning
- Quality management (Quality Management Systems)
- Risk Management
- Product and documentation review for compliance with standards and legal requirements
- Preparation of technical documentation and approval basis
- Obtaining certification from the certifying bodies
Hørsholm and Aarhus
Standards, directives and rule parts
MDD 93/42/EEC, 2007/47/EC, EMC 2014/30/EU, LVD 2014/35/EU, R&TTE 1999/5/EC, RED 2014/53/EU, FCC part 15 & Part 18, VCCI, Industry Canada, Australia / New Zealand ACMA, EN IEC 60601-1, EN IEC 60601-1-2, ISO 13485, CISPR22, CISPR32, CISPR24, CISPR11, CISPR14, CISPRxx, ETSI, CENELEC, IEC, IECEE, EN IEC 61000-6-1, EN IEC 61000-6-2, EN IEC 61000-6-3, EN IEC 61000-6-4, EN 301 489, EN IEC 60950, EN IEC 61010, and many more