Updated: Jul 25
Raising the Bar: ISO Certification and FDA clearances in Medical devices companies
Before making any decisions about personalized medical devices or surgical planning software, it's crucial not to overlook essential requirements that determine the safety and effectiveness of your choice. Cutting corners in these crucial factors can lead to disastrous consequences. Don't settle for mediocrity, demand excellence. Firstly, insist on ISO 13485 certification, a guarantee of rigorous quality management for medical devices that sets the industry standard. Secondly, ensure their device´s performance testing is conducted by GLP laboratories, proving the product's capabilities. Thirdly, look for FDA's 510(k) clearance, a regulatory stamp of approval that signals trust and compliance with strict requirements. Additionally, prioritize biocompatible materials like Polyetheretherketone (PEEK), biocompatible resins, and titanium to ensure seamless patient compatibility. Lastly, seek products backed by qualified personnel, the true experts who elevate your experience to the next level.
At TECHFIT, we take immense pride in our ISO Certification, which serves as a testament to the effectiveness of our quality management system, setting us apart from those who fail to meet these critical standards. We are not just another option; we are one of the leaders in personalized medical solutions. Don't settle for anything less.
As surgeon and/or patient you deserve a company with an unwavering commitment to exceptional standards, where the quality is reinforced by the extensive range of rigorous tests performed for FDA 510(k) clearance submissions.
These tests are conducted by certified GLP laboratories and include sensitization, irritation, cytotoxicity, bioburden, endotoxins, as well as mechanical tests such as compression and bending to ensure superior product performance.
Moreover, your products should have biocompatibility tests, thoroughly evaluating materials to ensure their safety and suitability for medical use. In addition, a comprehensive chemical characterization and dimensional validation tests, ensuring each device meets the highest quality and accuracy standards.
It is through this rigorous testing and adherence to the most strict quality standards that TECHFIT set themselves one step above others in the medical device industry.
TECHFIT Patient specific maxillofacial system on TECHFIT Diagnostic Models
Our journey began in 2021 with the 510(k) clearance of the TECHFIT Patient-Specific Maxillofacial System, an implantable device designed to stabilize, fixate, and reconstruct the maxillofacial/midface and mandibular skeletal regions.
Recognizing the importance of diagnostic accuracy and surgical planning, we introduced our second 510(k) cleared device, the TECHFIT Diagnostic Models earlier this year. These anatomic models are intended for diagnostic use during maxillofacial surgery planning. They are incredible tools for surgeons, enabling them to make precise diagnoses and formulate treatment plans based on the patient's unique anatomy.
Expanding our range of cleared devices, we are thrilled to announce our most recent achievement—the 510(k) clearance for the TECHFIT DISRP System. Comprising the Digitally Integrated Surgical Reconstruction Platform (DISRP) and Orthognathic Surgical Guides.
DISRP is a cloud-based collaborative platform for digital surgery case flow management and Orthognathic surgery planning that facilitates communication among surgeons, sales representatives, and the TECHFIT case planning staff using multiple devices. It allows easy collaboration in the surgical planning process. Being web-based, it allows immediate and convenient sharing without the installation or maintenance of the application at the user’s end.
Complementing the DISRP platform, our Orthognathic Surgical Guides are Patient-Specific single use devices that are designed to assist the surgeon in transferring the pre-surgical plan to the operation room.
These guides feature drilling holes, slots for and osteotomies, and precise positioning of bones and implants. Manufactured from commercially available titanium or 3D printed resin with metal sleeves.
With the clearance of the TECHFIT DISRP System, we are thrilled to offer a complete solution for every step of the orthognathic surgical planning process. From accurate diagnosis to meticulous surgical planning and the provision of implantable devices.
TECHFIT Titanium Orthognathic Surgical Guides
It is important to recognize that the critical nature of medical devices directly impacts patient outcomes, and that's why every company involved in manufacturing medical devices should strive to meet stringent standards. ISO Certification is not just a badge of honor; it signifies a dedication to quality management, instilling confidence in regulatory bodies and patients alike.
Embracing ISO standards allows companies to set new goals in healthcare by delivering safe and effective products.
TECHFIT stands as a pioneer in elevating healthcare innovations. With safety, precision, and patient well-being as our guiding principles, we aim to set industry standards for personalized medical solutions. Our extensive range of FDA 510(k) cleared devices is a testament to the quality of our products.
Choose TECHFIT and embark on a journey towards a healthier and happier future. Together, let's reshape healthcare for the better and inspire a new era of innovation