OECD GLP CERTIFIED BIOCOMPATIBILITY TESTING SERVICE

OECD GLP CERTIFIED BIOCOMPATIBILITY TESTING SERVICE

ISO10993、生物相容、FDA、毒理,動物實驗,醫療器材,健康食品,化學品

LEON Biotech has an international OECD GLP certified laboratory. Generally, the safety and effectiveness of medical devices is the major goal of product certification. Medical devices that directly or indirectly contact with the human body have to complaince with global ISO 10993 series international standard for safety risk assessment to ensure that the products passed pre-market approval. Into the request. With our experienced veterinarians and technical expertise in the companies, Leon Biotech already assist thousands of compnaies passed US FDA and Notify Body CE techinical review.Our testing report also widely acceptable by worldwide government authoriy for product submission.

Category

In vivo test / In vitro test

Test item

Method

Cytotoxicity

In vitro test

CytotoxicityISO10993-5

Irritaiton

In vivo test

Skin irriation ISO10993-10
Intracutaneous irritation
Oral mucosa irriation
Ocular irritation
Rectal irritation test
Penile irritation test/Vaginal mucosa irritation test

Skin Sensitization

In vivo test

Skin Sensitization

Acute systemic toxicity

In vivo test

Acute systemic toxicity ISO10993-11
Pyrogenic test USP151

Subacute systemic toxicity

In vivo test

14-28 days repeat dose systemic toxicity -Extraction methodISO10993-11
14-28 days repeat dose systemic toxicity -implantation method

Sub chronic systemic toxicity

In vivo test

28-90 days repeat dose systemic toxicity -Extraction method
20-90 days repeat dose systemic toxicity -Implantation method

Chronic systemic toxicity

In vivo test

180-365 days repeat dose systemic toxicity -Extraction method
180 365 days repeat dose systemic toxicity -Implantation method

Subchronic system toxicity (New)

In vivo test

14 days repeat dose systemic toxicity -extraction method

Genotoxicity

In vitro test

Bacterial Reverse Mutation Test OECD471
In Vitro Mammalian Chromosomal Aberration Test/ Cell Gene Mutation Tests Using the Thymidine Kinase OECD473

In vivo test

Mammalian Erythrocyte Micronucleus Test OECD474

Implanation

In vivo test

4-12 weeks Subcutaneous tissue/Muscle/BoneISO10993-6

Hemacompatilbity

In vivo test

in vivo ThrombogenicityISO10993-4

In vitro test

in vitro Hemolysis test(direct and indirect contact)ISO10993-4

In vitro test

Platelets / white blood cells analysisISO10993-4

In vitro test

Partial Thromboplastin Time (PTT)ISO10993-4

In vitro test

Complement Activation, SC5b-9 & C3aISO10993-4

ISO 10993-1:2018 the latest version of medical device biocompatiblity evaluation chart

X= Mandatory , E= Endpoint of final device evaluation , F= USFDA guidance request additional items

服務內容

 

美國

FDA 510(k)申請 (MD&IVD)
PMA申請
De Novo申請
FDA Pre-submission Service (FDA預審查申請及諮詢服務)
FDA Listing (註冊列名)

 

歐盟

1、歐盟醫療器械 CE 法規服務
2、CE 技術檔案建立與諮詢顧問
3、品質系統 ISO 13485 法規輔導諮詢
4、臨床評估報告 Clinical Evaluation Report/上市後監控(PMCF)與上市後追蹤諮詢(PMS)
5、歐體代表(Euro Rep)登錄服務
6、歐盟 Notified body 2195 SZUTEST
7、符合 MDR CE Mark/符合MDD CE Mark-2020/05月

 

台、韓、印、新

1.台灣TFDA I/II/III類醫材註冊
2.韓國KFDA/印度/新加坡國際註冊