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! There are also an increasing need for systems to manage CSR and IT security aspects on your business.
Trade compliance &
Export control applies to all companies. These regulations often falls under global agreements to prevent terrorism but also limit access of technology for some countries.
To keep or build required competence training is a must!
We do training and education activities in most areas. We are also active in holding seminars and speeches in conferences to keep you updated on the latest!
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!
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
Selected areas we provide training in
In this one day coarse we go through how to write and submit a 510(k). The best way is to include the contributors typical from R&D to get their understanding.
This coarse we have in cooperation with Swedish Medtech organisation. We explore and learn what the PRRC role is about and what to look out for!
CE marking of software products. In this one day coarse we go through the whole process from A to Z in what and how the documentation should look like.
How to get to the market with your product! In this half day course we explore how you should approach this, and what is needed to build a sustainable organisation for this.
How to meet the requirements in the quality mangament standard for Medical devices and IVDs. We also discuss compliance with MDR/IVDR/FDA-
One or two days coarse.
Leran how to prepare your organisation before, during and after the audit. Doing this right is very important for getting the right result for you! This is a half day coarse, preferable including all key members of your team that will face the inspectors.
In this one day coarse we go through what FDA expects from you in terms of meeting their quality system regulation.
What are the requirements, what do I need to have in place, how to... In this half day coarse you learn the basics in this regulation that every company needs to know
How to setup a compliance program to meet this regulation. In this halfday coarse we will drill down in all aspects of GDPR compliance.
In this one day coarse we go through everything a startup company needs to know and work with. We will use examples to visualize the challenges and what you can do to be able to be on top of them!
What to think about when you organize your compliance work. How to fit MDR, CSR, PRRC, GDPR, CSO and all other activites you need to manage.