SAFETY OF THE BIOMATERIAL

MARINE ORIGIN

Issued from the internal aragonite layer of the bivalve Pinctada maxima

 

Many scientific publications available on request

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Oyster2

ACELLULAR & NON VIABLE

Made of more than 95% of calcium carbonate

Bionacre is acellular and non-viable, thus preventing any bacterial or viral intrusion

 

Many scientific publications available on request

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BIOLOGICAL SAFETY TESTS  (in accordance with ISO 10993-1)

- Citotoxicity evaluation

- Genotoxicity (Ames Test)

- In vitro chromosome aberration test on human lymphocytes

- Delayed time hypersensivity

- Intradermal activity

 

Many scientific publications available on request

 

 

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Safety of the manufacturing process

 

In a regulatory strictly controlled environment


-By product, conception, development, production and post-market conditions in accordance with the requirements for Medical Device regulatory compliance.

-For each form of the biomaterial (powdered or solid), different controls in each key process step for a full safety and traceability evidence.

-Since the preparation and the receival of the raw material, several steps of pre-process decontamination and cleaning steps.

-During the manufacturing process, several physico-chemical treatments and externally completed biological tests in order to prevent from any production out-of-specifications.

-At the end of the process, sterilization through Gamma irradiation method.

-Post-market surveillance, in collaboration with professional leaders of distribution.

CERTIFICATIONS

Certificat002

EVALUATION AND CERTIFICATION

FOR ANY QUESTION CONTACT US AT WWW.MEGABIOPHARMA.COM

CONTACT
entreprise

Scientific Data – 25 years clinical experience and evaluation

 

-In vitro data, in particular in contact with human osteoblast cells, showing the full biocompatibility as well as the osteogenic properties

-In vivo preclinical data (sheep, rabbits), about the use of plates and screws for orthopedics, which have demonstrated the osseointegration and were subject of publications

-Data collected on human clinical cases (dental, orthopedics), in particular through the use of the powdered form of the biomaterial (bone substitute, for reconstruction of alveolar ridge or loss of substance for example).

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-Complete Clinical Evaluation in accordance with the regulatory requirements (MEDDEV 2.7/1 rev.4)

CONTACT
Labo

Safety of the manufacturing process

 

In a regulatory strictly controlled environment

 

-ISO 13485:2012 company certification.

-By product, conception, development, production and post-market conditions in accordance with the requirements for Medical Device regulatory compliance.

-For each form of the biomaterial (powdered or solid), different controls in each key process step for a full safety and traceability evidence.

-Since the preparation and the receival of the raw material, several steps of pre-process decontamination and cleaning steps.

-During the manufacturing process, several physico-chemical treatments and externally completed biological tests in order to prevent from any production out-of-specifications.

-At the end of the process, sterilization through Gamma irradiation method.

-Post-market surveillance, in collaboration with professional leaders of distribution.

Mega Bio Pharma®