Arabella for Medical Technologies has reached a significant milestone by achieving Medical Device Regulation (MDR) certification from SGS for its two sites in Jordan and Egypt. This achievement reinforces Arabella’s commitment to providing innovative and high-quality medical solutions, ensuring compliance with the latest regulatory requirements across global markets.
This certification enhances Arabella’s ability to expand its presence in other countries, demonstrating its dedication to patient and medical personnel safety while meeting the evolving regulatory landscape for medical devices.
About Arabella for Medical Technologies
Founded in 2014, Arabella for Medical Technologies specializes in manufacturing high-quality and cost-effective medical products, catering to the specific needs of healthcare providers. Operating from two facilities in Jordan and Egypt, Arabella focuses on delivering Sterile Surgical Gowns and Drape Packs, produced using advanced manufacturing technologies, sterilized to client specifications, and designed to enhance the safety of both patients and healthcare professionals.
The Significance of MDR Certification
The MDR (Medical Device Regulation) certification is a globally recognized regulatory framework that ensures medical devices comply with the highest standards of safety, performance, and clinical efficacy. Achieving MDR certification reflects Arabella’s dedication to continuous improvement and adherence to stringent European medical device regulations.
By obtaining this certification, Arabella strengthens its position in the medical device industry, reinforcing customer trust, expanding market access, and ensuring compliance with global healthcare standards.
Key Benefits of MDR Certification for Arabella
Achieving MDR certification provides Arabella with multiple advantages, including:
- Expanded Global Market Access: Meeting international regulatory requirements facilitates entry into new markets.
- Enhanced Patient & Medical Personnel Safety: Ensuring the highest standards of product quality and risk management.
- Regulatory Compliance Excellence: Demonstrating commitment to strict European safety and performance standards.
- Strengthened Customer Trust: Showcasing dedication to delivering compliant and high-quality medical products.
The SGS audit added great value. Achieving certification enhances our compliance, expands global market access, and strengthens our competitive edge.
Arabella’s MDR certification reflects their commitment to safety, quality, and regulatory excellence in medical devices, setting benchmarks for MD manufacturers in the region.
About SGS
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of 99,500 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and trusted specialized brands, including Brightsight, Bluesign, Maine Pointe and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH0002497458, Reuters SGSN.S, Bloomberg SGSN:SW).
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