Today’s cosmetic industry is easily the safest it’s ever been. With more and more consumers flocking to med spas and plastic surgery clinics, the quality of cosmetic technology and the overall focus on safety has improved remarkably. But as a provider or patient, you can’t scrutinize everything. Bad products and devices may still slip through the cracks.
So, what distinguishes a bad product from a good one? What certifications should cosmetic providers keep an eye out for and what are the consequences of poor due diligence as a patient or as a provider?
As a patient, you’d rather not leave anything to chance. The last thing you’d expect after a cosmetic procedure is to be left disfigured, sick, or in need of serious medical help. And as a provider, you know that using unsafe devices can lead to litigation and even the end of your practice as you know it.
Unsafe devices, procedures, and technology can have dire consequences, up to and including disfigurement, bankruptcy, and even death. For these reasons, we stopped at nothing to ensure that PDO Max Threads went above and beyond to become the #1 PDO thread on the market today.
Here’s how you can trust PDO Max Thread’s commitment to utmost safety.
The Food and Drug Administration of the United States is tasked with ensuring consumer safety among a range of products, including medications, medical devices, and other biological products. Any product that receives FDA clearance can be legally marketed and sold safely within the United States.
During the certification process, the FDA reviews the device in question and compares it to other similar products that may have already been cleared for sale. The product ultimately receives 501(K) certification, distinguishing it as fit for sale to American consumers.
FDA clearance is a necessary hurdle for selling any medical device to consumers. PDO Max Threads have been FDA cleared through the 501(k) certification process, confirming their safety and efficacy as a cosmetic product. You can even see our FDA certification for yourself here.
ISO 13485 Certification
The FDA may handle domestic certification for medical devices, but what about international certification? To market and sell your medical device in other nations, it helps to have certification from the International Organization for Standardization (ISO). The ISO is an independent, non-governmental body headquartered in Geneva, Switzerland.
Since 1946, the ISO—made up of engineers, industry experts, scientists, and others—has dedicated itself to uniformity in products and standards of engineering across the world. These standards extend to include safety, especially in medical devices.
PDO Max Threads had to clear a high bar to ultimately receive ISO 13485 certification—a badge of pride for any medical device on the market today. But what does ISO 13485 certification mean?
“ISO 13485 Certified” means that an organization has implemented an ISO 13485 quality management system and has successfully met all of the requirements to prove that every reasonable step has been taken to ensure safety. ISO 13485 evaluates whether a manufacturer’s quality management system is appropriate and effective while emphasizing the safety and efficacy of medical devices.
At PDO Max, we maintain ISO 13485 certification from the manufacturer’s shop floor all the way to your office doors. Both our threads and cannulas bear the distinction, meaning that you can trust the device and the cannula it comes in.
For more information about the rigorous standards required to earn this certification, you can read about it from the organization itself here.
Safe for Sale & Use
With 7 billion people in the world (and counting), it’s not always possible to anticipate bad reactions, fluke procedures, and one-in-a-million accidents. But by performing your due diligence ahead of time—as both a provider and a patient—you can give yourself the confidence you need to administer and receive safe cosmetic treatments.
PDO Max Threads were, in part, born out of the frustration of seeing so many similar and unsafe products for sale on the market. Our response was to prove to other manufacturers (and the cosmetic world at large) that PDO threads could be engineered affordably and safely. In fact, we’ve done just that.
Our commitment to safety extends past engineering and certifications. That’s why we offer comprehensive training for providers, teaching them techniques, safety protocols, and even how to market their services while maximizing their ROI. Let PDO Max Threads create a new avenue of revenue for your practice today!
Proven safe, proven reliable—PDO Max Threads
We pulled out every stop to make PDO Max Threads the #1 product on the market for restoring indicators of beauty. Patients and providers can trust our threads without hesitation, safe in the knowledge that domestic and international bodies have singled them out as a safe and effective medical devices. Hardly content with just FDA clearance, we’ve run our threads by the best available safety organizations just to make sure. To learn how much value PDO threads can add to your practice, click here.