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Product safety

Orthoss® and Chondro-Gide® are CE-marked medical devices

Orthoss® and Chondro-Gide® are amongst the leading products for bone and cartilage regeneration in orthopaedic surgery with a long-standing record of highly successful clinical use throughout the world.

Geistlich Pharma is a quality-driven company that endeavours to provide patients with clinically proven and effective products.

As medical devices Orthoss® and Chondro-Gide® are covered by national regulatory frameworks which require thorough documentation as prerequisite for market approval.

The directive 2003/32/EC, an extension of the medical device directive 93/42/EEC, requires that manufacturers of medical devices derived from animal tissues justify the use of such products with regard to the clinical benefit for the patient within the framework of a risk management procedure and taking into account the available alternatives.

The normative requirements for the evaluation are specified in the guideline series ISO 22442.

Both Orthoss® and Chondro-Gide® have CE-marking certification as medical devices assuring their conformity with mandatory safety regulations and confirming that risk-benefit evaluation was performed in compliance with the norms.

The manufacturing processes, adherence to the strict control measures and clinical documentation are in accordance with a quality assurance system based on international standards (ISO 13485 and ISO 9001), and subject to continuous inspection by the competent authorities and regulatory bodies.

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Dr. Sanja Saftic
International Product Manager