There are many regulatory requirements that effects companies, Acronyms like IVDR, MDR, FDA, CFR, MD, FCC. EMC, USdot, NRC, WEEE, Rohs and REACH. All represent possible pitfalls to ensure predictable market access.
In most regulations for IVD and Medical devices it is a must to have a management system covering the activities needed.
Many companies does not know that they also need to follow many different rules when it comes to trade compliance. These regulations often falls under global agreements to prevent terrorism but also limit access of technology for some countries.
We are AR within EU! just contact us to get more information about prices and additional services we can provide you with!
We are Person Responsible for Regulatory Compliance for many companies in northern Europe. Contact us for mer information what we can help you with!
We have developed a way of working that help startups or smaller companies to get to the EU market in a easy, compliant and predictable way!
Do you need a global or local strategy for how to get your products to the market!
Classification of the product defines what rules that applies to your product!
Do you have the documentation needed för CE marking or 510(k) submission
We can help you to perform internal audits, set up the system or give advice on what to do!
Do you need to implement or develop mangament systems in ISO 27001, ISO 14001, ISO 3485 and ISO 9001.
Have you got a letter from FDA or competent authority about inspection or need help in Notified Body audits! contact us!
Not having an export control system, to classify products, check customers, and sub suppliers, involved banks etc. Then it is time ta contact us now!
Help in establishing ECCN codes and other important product related classifications. Do you have US content or not?
We can support in obtaining US (BIS, OFAC), EU or national licenses to export to e.g. embargo or restricted countries. The needs are based on product classification and countries you sell to
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