Arok Healthcare, an emerging pharmaceutical and healthcare company, is delighted to announce that it has obtained EU MDR certification for its medical device products.
This certification marks a pivotal moment for Arok Healthcare and confirms the conformity of our medical device products with the strict requirements of the Medical Device Regulation (MDR).
Delivering high-quality Medical Devices in Europe and worldwide
The EU Medical Device Regulations (EU MDR 2017/745) is recognised internationally and sets quality standards for medical devices sold in the European Union, with an emphasis on safety, risk management and post-market surveillance. It replaces the former Medical Device Directive 93/42/EEC (MDD), introducing a more stringent framework and heightened requirements for continued access to the European market. Obtaining the EU MDR certificate highlights Arok’s mission to ensure access to medical devices while upholding the highest standards of regulatory compliance.
With this certification, Arok Healthcare will continue to supply and market its CE-marked medical devices portfolio in the European Union and internationally.
Commenting on the Annette Dolan, Person Responsible for Regulatory Compliance noted “Obtaining this certification is not only a significant achievement and milestone for Arok but I am proud of our teams hard work and ongoing commitment to quality and regulatory compliance standards”
CEO at Arok Healthcare, Conor O’Daly, further commented “Receiving the new CE certification for our Relactagel and Regelle brands under the EU MDR is a testament to the dedication and hard work of the entire team. I want to congratulate the team for this remarkable achievement. This accomplishment reflects our unwavering commitment to delivering high quality, safe and reliable medical devices to our customers and patients. We are excited to continue serving our European and International distributors while exploring new opportunities with this certification.”
or further information please contact info@arokhealthcare.com or contact +353 (01)8900406