incantis GmbH

medical devices

About

incantis GmbH is a German consulting firm based in Weidenberg, Bavaria, specializing in the medical devices and pharmaceutical industries. Founded in 2009, the company focuses on quality management systems (QMS) and regulatory compliance, offering tailored solutions to help clients meet international standards. The core services provided by incantis GmbH include the creation and remediation of QMS aligned with ISO 13485:2016 and ISO 9001:2015, regulatory affairs consulting, risk management based on ISO 14971:2019, and process validation. They also assist with technical documentation, audit preparation, post-market surveillance, and provide hands-on support for implementation and training. Targeting small to medium-sized enterprises, incantis GmbH supports innovative product development from concept to market approval. The company values a collaborative culture and emphasizes continuous development to ensure high performance and reliability in their consulting services. With certifications in key quality management standards, incantis GmbH has extensive experience across various projects in the healthcare sector.

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Keywords

qms iso 13485 risk management lean qms technical writing iso14971 medical device regulation technical documentation document management validation postmarketsurveillance medical devices audit remediation audit preparation mdsap handson support iso 9001 workshops gmp csv mdr ivdr medical equipment manufacturing safety assurance case validierung regulatorische anforderungen audit-vorbereitung 510(k) prozessoptimierung requalifizierung schulungen

Location

7 Spinnereistrasse, Bayreuth, Bayern, Germany, 95445

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