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The Stage I audit for ISO 13485 at the end of January 2026 had already demonstrated that the necessary structures and processes were fully in place within the company. This impression was confirmed and further reinforced during the Stage II audit for ISO 13485 and the recertification audit for ISO 9001 in early February 2026. Particular praise was given to, amongst other things, the high level of competence and the strong awareness of staff in quality-related and regulatory activities.

“It is important for our clients that they can rely not only on technical expertise, but also on systems and processes that prove their worth in day-to-day operations and during audits,” says Ralf G. Sibbing, Managing Partner of TentaConsult Pharma & Med GmbH. “The new ISO 13485 certification and the renewed ISO 9001 certification underline precisely this commitment.”

Certified quality as the foundation of our services!

The successful completion of the audits and the new certification also highlight what has long underpinned TentaConsult’s work: the combination of regulatory consultancy with carefully managed and transparent quality practices. The certified activities encompass regulatory services, consultancy and expert assessment in the fields of medical devices and human medicinal products. In the field of substance-based medical devices, this is supplemented by the design, development and management of production on behalf of third parties. Based on ISO 13485 and the MDR, TentaConsult acts as the legal manufacturer of medical devices or fulfils roles such as that of the responsible person under Article 15 of the MDR (PRRC).

Building on this, TentaConsult also supports companies with further regulatory and quality-related issues throughout the product lifecycle. The company assists with the preparation and maintenance of technical documentation, conformity assessment, clinical evaluation and biocompatibility, as well as with the implementation, support and further development of quality management systems. In addition, we provide support right through to market access and beyond, into post-market surveillance, where existing structures need to be further developed, secured or maintained in a stable state during ongoing operations.

Another key focus is on services involving direct responsibility. These include taking on quality management functions (QMB), managing complete quality management systems, integrating individual outsourced processes into TentaConsult’s quality management system, and Acting as an EU importer or EU Authorised Representative (EU-REP) for manufacturers based outside the European Union.

In these roles, TentaConsult supports the associated activities and formalities within the scope of the respective mandate, reviews the EU Declaration of Conformity and the technical documentation, provides support in connection with the conformity assessment procedure, handles communication with authorities, and offers assistance in relation to EUDAMED and relevant post-market surveillance activities. For manufacturers outside the European Union, this means having a point of contact based within the Union who not only understands regulatory requirements but also provides reliable support in their practical implementation.

ISO 13485 certification and the renewed ISO 9001 certification therefore signify more than just a successful audit. They also demonstrate that a company supports its customers in regulated markets with technical precision, a focus on quality and a wide range of services.

Interested companies can obtain further information about TentaConsult’s services directly from TentaConsult.

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