Implantica Achieves MDSAP Recertification Signifying High Standards in Medical Device Compliance

Implantica Achieves MDSAP Recertification

Implantica AG, a pioneering MedTech company known for introducing advanced technologies into the human body, recently announced a significant achievement: the successful completion of its Medical Device Single Audit Program (MDSAP) recertification audit. This achievement ensures that Implantica operates at the highest international standards concerning quality management and regulatory compliance.

The MDSAP allows for a single regulatory audit of a medical device manufacturer's quality management system that meets the requirements of multiple jurisdictions. This not only streamlines the compliance processes but also assures global authorities of the company's commitment to safety and efficacy.

Conducted by Implantica's notified body, BSI, the audit reaffirms the company's dedication to maintaining superior quality and adherence to regulations across various markets, including Europe, the United States, Canada, and Brazil. By renewing certifications in these critical regions, Implantica is positioning itself for significant growth in the medical technology arena.

Future Plans and Regulatory Developments

Looking ahead, Implantica is preparing for upcoming applications in Canada and Brazil, planned for submission in 2026. These initiatives will follow the completion of FDA inspections at the company's manufacturing site in Malta. Notably, the U.S. Food and Drug Administration (FDA) has confirmed the inspections will proceed as scheduled, despite the ongoing U.S. government shutdown.

Moreover, to facilitate better engagement during the review process, the FDA has rescheduled the 100-Day Meeting to October 10th. This adjustment ensures that all review personnel can attend, further strengthening the collaboration between Implantica and the regulatory body.

Commitment to Patient Safety and Innovation

Dr. Peter Forsell, CEO and founder of Implantica, expressed pride in this achievement, stating, "Successfully completing the MDSAP recertification audit once again demonstrates Implantica's unwavering dedication to patient safety, product quality, and regulatory excellence. As we continue to expand our global presence, maintaining world-class standards across every market is fundamental to bringing our breakthrough implantable technologies to patients in need."

This momentous achievement serves as a testament to Implantica's mission of revolutionizing the treatment of chronic health conditions through innovative smart medical implant technologies. With pioneering products like RefluxStop, which addresses acid reflux — a condition affecting over one billion individuals globally — Implantica is set to reshape the landscape of anti-reflux treatment.

About Implantica & RefluxStop

Implantica is a MedTech group focused on incorporating advanced technologies within the human body. Its leading product, RefluxStop, is a CE-marked implant aimed at preventing gastroesophageal reflux. Clinical trials have shown promise in creating a paradigm shift in anti-reflux treatments, distinguishing it from traditional surgical solutions by restoring the lower esophageal sphincter without exerting undue pressure on the esophagus.

The RefluxStop mechanism effectively reconstructs critical components of the anti-reflux barrier. By restoring the body's natural anatomy, it allows the system to address acid reflux independently, thereby reducing the risk of complications often associated with traditional surgical procedures.

As Implantica takes significant strides in global markets, it remains dedicated to innovation and patient-centered solutions, paving the way for a new era in medical implants and therapies. More information about Implantica and its groundbreaking products can be found on their official website.