Chemence Medical, Inc. has received CE Mark Certification for their sterile topical skin adhesives under the new Medical Device Regulations (MDR). The EU MDR is the set of regulations that governs the worldwide production and European distribution of medical devices. Compliance with this regulation is mandatory for medical device companies to legally market and sell their products in the EEA (European Economic Area). As part of the new regulations, all manufacturers of medical devices for sale within the EU must adhere to more strict guidelines to ensure their products are safe to use.
In addition to receiving EU MDR CE Certification, Chemence Medical Inc. has also obtained certification under the Medical Device Single Audit Program (MDSAP). This is a voluntary program which allows a single audit of a medical device manufacturer’s Quality Management System (QMS) to satisfy the requirements of multiple regulatory jurisdictions, including the US, Canada, Australia, Japan and Brazil. There are also options to include ISO 13485 quality certifications as a part of this audit. Audits are conducted by Auditing Organizations which are authorized by the participating Regulatory Authorities (RA) to audit under MDSAP and ISO 13485 requirements.
Chemence Medical, Inc.’s Chief Executive Officer James Cooke stated, “Obtaining MDR & MDSAP sets us apart from our competitors that have not yet obtained these certifications. It underlines our commitment to our customers and regulatory authorities that we are reliable, trustworthy, and committed to quality.”
About Chemence Medical
Chemence Medical, Inc., headquartered in metropolitan Atlanta, GA, has redefined the medical adhesives industry. Our team has become a world leader in the medical device arena since its beginning in 1994. Chemence Medical manufactures and distributes adhesive-based medical devices used by many of the largest medical centers around the globe. Many of the company’s products are protected by a portfolio of patents covering various aspects of cyanoacrylate and medical technologies.
Chemence Medical, Inc.
Charnelle Thomas, Vice President of Regulatory Affairs