be-on-Quality GmbH

medical devices

About

be-on-Quality GmbH is a consulting company that specializes in quality management, regulatory affairs, and clinical affairs for medical devices and in-vitro diagnostics. They support manufacturers throughout the product lifecycle, from initial concept and regulatory strategy to approvals and market access, ensuring compliance with standards like the Medical Device Regulation (MDR) and ISO 13485. The company has a team of experts who work closely with clients through direct cooperation, project-oriented setups, and tailored workshops and training sessions. Their services include regulatory consulting, quality management system implementation, clinical affairs consulting, and customized regulatory strategies. They focus on enhancing clients' internal capabilities and understanding of regulatory requirements. Headquartered in Reichenschwand, Germany, with an additional office in Neunkirchen am Sand, be-on-Quality GmbH emphasizes building strong partnerships with manufacturers and developers in the medical device industry to provide effective solutions for regulatory compliance and quality assurance.

Technologies

Outlook WordPress.org Apache Mobile Friendly AI

Keywords

regulatory affairs medical devices mdd medical device regulation mdr quality management apps & wearables risk management mdr iso14971 62304 60601 medical equipment manufacturing iso 13485 conformity assessment product requirements check technical documentation review product classification product approval consulting standards compliance approval strategy planning clinical evaluation iso 14971 services safety reports support for software validation ivdr fda 510(k) safety reporting vigilance system

Location

33 Lilienstrasse, Reichenschwand, Bavaria, Germany, 91244

Related Companies

Companies in the same industry