Certification Support Services

Professional Certification Support Services


Professional Certification Training Services

Unlike traditional consultancy services, Ankalaps is at your side with a service understanding.

So what do we do; We do not prepare your files related to the quality management system. We provide all the support and training you need to prepare.

ISO 13485-2016 KYS

Medical Devices Quality Management System Installation

ISO 13485 - 2016 was published in recent years. Until March 2019, companies were required to certify their Quality Management Systems according to the relevant standard. As Ankalaps, we provide consultancy support to companies on related subject. As Ankalaps, we believe that every company should make the necessary efforts to establish and maintain this system in its own structure. In fact, we strongly recommend that companies establish a department for this issue in their own premises for efficiency and continuity in the future. We provide installation and commissioning of the system within a certain period of time. We also contribute to the integration of QMS logic into your personnel culture by performing periodic checks.

Technical File Preparation

Professional Product Technical File Preparation Service

In the Medical Device Industry, the preparation of Product Technical Dossiers is a very laborious and long process. It is of utmost importance that the personnel preparing the technical dossier have sufficient knowledge of the relevant standards as well as medical knowledge.

Likewise, in the technical dossier, the product must be proved by objective evidence in a way that does not leave any comment on the following issues. We provide training to your staff about how to make these proofs.

Clinical Evaluation

Professional Conformity Assessment Process Service

The most important chain of conformity assessment procedures is biocompatibility testing.

Biocompatibility is the optimal adaptation of a biomaterial to physical, chemical, biological adaptation to body tissues and to the mechanical behavior of the body. Biocompatibility is the ability of the material to respond appropriately to the body.

At Ankalaps, we are ready to assist you in the biocompatibility and clinical evaluation of your product.