Koplak is FDA and ISO 13485 certified for the development and manufacturing of medical devices.

At our company, dedicated to the development and manufacturing of medical devices, having FDA and ISO 13485 certifications is not only essential but also a fundamental pillar for our operation and growth in the global market. Thanks to these certifications, we are qualified to design, develop, manufacture, and assemble medical devices and supplies, ensuring the highest quality and the latest in technology.

Importance and Benefits of ISO 13485 Certification for Our Company

ISO 13485 certification is an internationally recognized standard that defines the requirements for a quality management system specific to the medical device industry. For our company, dedicated to the development and manufacturing of high-quality medical equipment, having this certification is not only a significant achievement but also a guarantee that our products meet the highest standards of quality and safety.

What Does ISO 13485 Certification Provide Us?

REGULATORY COMPLIANCE

ISO 13485 is aligned with global regulatory requirements, such as those established by the FDA in the United States. This facilitates the commercialization of our products in various international markets, ensuring that we comply with the applicable regulations and standards in each country.

CONTINUOUS PROCESS IMPROVEMENT

Implementing a quality management system based on ISO 13485 requires us to continually review and improve our processes. This leads to greater operational efficiency, reduced errors, and ultimately, better-quality products for our customers.

CUSTOMER CONFIDENCE

Being certified under the ISO 13485 standard gives our customers full confidence that our medical devices have been developed and manufactured following the strictest quality controls. This strengthens our reputation in the market and positions us as a reliable provider committed to the safety and effectiveness of our products.

RISK REDUCTION

ISO 13485 emphasizes risk management throughout the entire product lifecycle. This allows us to identify, assess, and mitigate the risks associated with our medical devices, minimizing the possibility of failures and ensuring a high level of safety for end users.

MARKET COMPETITIVENESS

Having ISO 13485 certification not only allows us to enter new markets but also differentiates us from the competition. Customers and business partners prefer to work with companies that demonstrate a solid commitment to quality, which opens doors to new business opportunities.