EU, US, Asia, South America.
The IWA Consulting Team is a dedicated group of regulatory affairs specialists providing expert services to a range of international private and public clients. We do that based on our long term regulatory experience, in-depth knowledge and expertise. We assist biotech, pharma, and medtech companies in achieving their major regulatory milestones, knowing and thoroughly understanding the sense of urgency that applies to this business area. Regulatory affairs – in every aspect of the discipline – is our core competence.
Areas of regulatory/reimbursement support:
Defining and implementing the regulatory strategy on how to market new or innovative medical devices – from idea to marketing. We have in-depth experience with: Successful development of Medical Devices. Timely product registration in EU (CE marking), US (IDE, PMA, 510(k)), Asia, etc. Reviewing and updating clinical evaluations / medical writing. Writing technical files, design history files, and product submissions incl design dossiers. Vigilance processes for Medical Devices including reporting of adverse events to relevant authorities and Market Corrective Actions (Recalls). Defining and implementing Quality Management System procedures required to market Your Medical Device.