Resyca BV successfully recertified for ISO 13485 – valid until 2028
We are pleased to announce that Resyca BV has successfully renewed its ISO 13485 certification, securing validity until 2028.
This recertification underscores our commitment to maintaining the highest standards in quality management and regulatory compliance.
Since obtaining our initial certification in 2022, we have continuously expanded and strengthened our quality framework, achieving additional certifications, including compliance with the Medical Device Regulation (MDR). These milestones reflect our dedication to ensuring robust processes that align with regulatory requirements, enabling us to develop and deliver innovative soft mist inhalers and drug delivery solutions.
This achievement would not have been possible without the outstanding efforts of our team. Special thanks to Dr. Raimund Gleixner, Danish Mairaj, and everyone involved for their expertise and dedication in managing and improving our quality system.
At Resyca, we remain committed to excellence in inhalation drug delivery and will continue to drive innovation while meeting the highest regulatory and quality standards.
About Resyca®
Resyca® was founded in 2020 and is a joint venture between Bespak and Medspray. Resyca® specialises in the development and manufacturing of compact, user-friendly soft mist inhalation and soft nasal spray devices, incorporating the proprietary Medspray micro-nozzle technology. These devices are tailored for pulmonary and nasal applications, utilising standard pre-filled syringes / primary packaging and filling lines. As the soft mist development centre within Bespak, Resyca offers comprehensive services spanning from early-stage development through to commercial production, inclusive of filling, labelling, and packaging.
For further information and interview opportunities with Resyca®, please contact:
Bernhard Müllinger at Resyca BV
Email: info@resyca.com
Website: www.resyca.com