We produce high quality ophthalmics products and distribute them all over the world.

Frastema, a leading ophthalmical device manufacturer, proudly announces its achievement of the prestigious ISO 13485 certification. This milestone demonstrates Frastema’s commitment to the highest standards of quality, safety, and regulatory compliance in the ophthalmical device industry.

ISO 13485 is an internationally recognized standard that specifies requirements for a quality management system (QMS) tailored to the design, development, production, and distribution of medical devices. Achieving this certification is a significant accomplishment, as it signals Frastema’s adherence to strict protocols and processes, guaranteeing the delivery of safe and effective ophthalmical products to eye care professionals and patients alike.

The certification process involved a comprehensive audit and evaluation of Frastema’s operations, systems, and quality management practices by an independent accreditation body. This assessment scrutinized all aspects of the company’s operations, including research and development, manufacturing, supply chain management, customer support, and post-market surveillance.

Earning the ISO 13485 certification is a testament to Frastema’s commitment to continuous improvement and dedication to meeting and exceeding customer expectations. By implementing and maintaining the standard’s requirements, the company ensures the consistency and reliability of its ophthalmical devices, fostering trust among eye care professionals and patients worldwide.

Frastema’s journey to achieve ISO 13485 certification involved considerable investments in technology, infrastructure, and employee training. The company focused on streamlining processes, enhancing risk management procedures, and fostering a culture of quality and compliance throughout the organization.

In a statement “Receiving ISO 13485 certification is a moment of immense pride for all of us at Frastema. It reflects our unwavering commitment to patient safety, product excellence, and continuous improvement. With this certification, we aim to strengthen our position in the market and expand our reach to serve more eye care professionals and patients worldwide.”

The ISO 13485 certification not only opens up new business opportunities for Frastema but also signifies its readiness to navigate the complex regulatory landscape governing ophthalmical devices across different countries. This certification will facilitate the company’s expansion into new markets and collaborations with global partners who prioritize the highest standards in ophthalmical device manufacturing.

Frastema’s achievement of ISO 13485 certification sets a benchmark for the industry, encouraging other ophthalmical device manufacturers to follow suit and elevate the overall quality and safety of eye care products. As the demand for advanced ophthalmical technologies continues to grow, such certifications become paramount in building trust and confidence among stakeholders.

As Frastema embarks on its ISO 13485 certified journey, the company reaffirms its commitment to innovation, patient well-being, and overall excellence in the ophthalmical device industry. With a focus on delivering cutting-edge products backed by robust quality management systems, Frastema is poised to make a lasting impact on global eye care delivery and patient outcomes.

About Frastema: Frastema is a renowned ophthalmical device manufacturer with a rich history of providing high-quality and innovative products to the eye care community. With a diverse range of ophthalmical devices catering to various specialties, Frastema continues to be at the forefront of advancing eye care solutions globally.

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