Expert on Human Drugs & Biologics

Inge Wallø Andersen IWA Consulting APS Ølbycenter 7,1 DK-4600 Køge Denmark Phone: +45 56660490 Fax: +45 56660491 Email: iwa@iwaconsulting.dk Web: www.iwaconsulting.dk

IWACONSULTING APS provides health care companies with assistance in Regulatory Affairs. IWACONSULTING APS provides expert advice and assistance on mutual recognition procedures and centralised procedures. IWACONSULTING APS has more than 25 years' experience in Regulatory Affairs based on previous corporate experience Regulatory Affairs in both Europe and the US, making the company eminently qualified in submission strategies in the EU for US based companies, and vice versa.

IWACONSULTING APS has extensive experience in handling EU procedures and publishing eCTD’s.

Expert on Medical Devices 
 

Henrik Kvistgaard Medical Device Consult ApS Brordrupvej 64 DK-4000 Roskilde Denmark Phone: +45 4557 0331 Email: info@medecon.dk Web: www.medecon.dk

Medical Device Consult (MDC) is a Danish based consulting company founded in 1995. MDC has specialised in assisting Medical Device and In-Vitro Diagnostic companies in meeting the US & European regulatory and Quality System requirements.
>MDC can assist companies through interpretation of the regulatory requirements relevant for the product in question and a range of services to facilitate the CE marking process in Europe or the 510(k) & PMA process with US FDA.
Developing, implementing and maintaining a Quality Management System in accordance with ISO 13485:2003 and FDA QSR part 809 & 820, specifically encompassing the processes relevant for your company, is among the tasks where MDC can offer you practical assistance.

The Quality Management System is developed in an interactive process with the company to accommodate specific needs and, to the extent it is relevant, incorporate regulatory requirements.