FGM’s regulatory processes guarantee safety and quality to the final result

For each type of product, there is a methodology to be applied and, for each phase of the production process, there is a team focused on running tests

In order to develop, produce and sell a quality product, technical knowledge, method and investment in science are necessary. Delivering high-performance products to the customer is one of FGM’s principles, which is why the company’s regulatory processes are essential to achieve amazing results. Quality control in the production process and customer service, a body of research and national and international certifications are some of the processes that guarantee product excellence.

According to the CEO, Bianca Mittelstädt, research and scientific validations ensure the high quality that meet the client’s needs and expectations, both in Brazil and in the foreign market, and these are indispensable values for FGM.

“Scientific foundation generates credibility. There is nothing like being able to prove your product’s quality and safety through scientific-based proof”, states the CEO Bianca Mittelstädt.

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Quality from start to finish

Contrary to what many imagine, quality control is not only done at the end of the manufacturing process. In fact, it is done from the very beginning when the product is still in the planning phase and continues throughout the entire production process until the final packaging.

“The great differential at the FGM’s quality department is the mutual understanding that we are not just a sector, but we share the same responsibility where the final customer’s satisfaction is our main mission”, says FGM’s Quality manager, Gisela Cristina Nass de Andrade.

To achieve its objectives, the FGM Quality team’s inspection routine involves several areas of product knowledge and uses tools and methodologies to ensure the sustainability of the actions. An example of this is the certainty that all production processes are inspected and released by the Quality team, from supplier to separating the order for the customer.

“Additionally, multisectoral programs such as the Quality Control Circle (QCC), Quality Week and Process Inspection are used as internal tools to promote and support our motto: ‘Quality is made by you!’”, Gisela explains.

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Audits and certifications

According to Tiago Ribeiro, management and regulatory system manager at FGM, 2022 was an intense year for FGM Dental Group, when it comes to Quality System audits.

“During this year, we went through nine audits, in the month of May alone we broke the record with four audits, two of which took place simultaneously with six auditors and, even so, we earned the recommendation for the MDR (Medical Device Regulation) and MDSAP (Medical Device Single Audit Program) certificates. With the certifications, the company can meet the requirements of several countries, such as Brazil (ANVISA), USA (FDA) and Canada (Health Canada)”.

In addition to the MDR and MDSAP certificates, in 2022, FGM renewed important certificates that guarantee the quality of its work, such as the Certificate of Good Manufacturing Practices for the Dentscare unit and for maintaining the Sanitary Permit at the Whiteness unit, audits to renew these certificates are done by the Sanitary Inspection agency. In order to maintain the European CE certification, FGM underwent two types of audits: Critical Supplier Audit, carried out by BSI, and the complex Microbiology Audit, focused on the Arcsys line of sterilized products.

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Research projects

The FGM Dental Group stands out for being close to the scientific community and its large investment in research.

“For some years now, the company has had the practice of sponsoring university research projects, which can be doctoral, master’s, specialization or graduate projects”, explains the manager of R&D and Technical Consulting, Alex Miura.

“Interested parties submit their research project proposals through the FGM website, which are reviewed by an internal multifunctional committee. Every applicant has their project evaluated and receives feedback from the company”, explains Miura.

FGM has already evaluated projects submitted by more than 150 institutions in Brazil and abroad. Some of the projects approved are published in scientific journals.

Do you want to know how to submit your research project to FGM? Access here and send your scientific proposal!

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