Services

Medical Device Training Program

ItemCourse Name
1ISO 13485 2016 Quality system regulation training
2Design Development & Control Process
3 ISO 14971 Risk managmnt program
4Post Market Survallience
5Process Validation course
6Software Validation course
7Sterlization Validation
8Package Validation
9Biocompatbility evaluation
10UDI (Unique Device Identification System )
11TFDA Device Registration Pratice
12US FDA 510K submission Pratice
13QSR (Quality System Regulation ) Pratice
14CE technical document regulation and writing pratice
15Clinical evaluation report writing pratice
16Medical Device Import QSD requirment

服務內容

 

1. ISO 10993及中國GB/T 16886 生物相容性試驗方案規劃

ISO 10993-1 生物相容性試驗風險評估/項目規劃
ISO 10993-3 基因毒性試驗(沙門氏菌回復突變試驗/體外哺乳動物細胞基因突變試驗/體外哺乳類染色體結構畸變試驗/囓齒類週邊血液微核試驗)
ISO 10993-4  血液相容性試驗(溶血試驗/血栓試驗/補體啟動試驗/血小板黏附試驗/凝血試驗)
ISO 10993-5 體外細胞毒性試驗
ISO 10993-6 肌肉植入試驗
ISO 10993-6 皮下植入試驗
ISO 10993-6 骨植入試驗
ISO 10993-10 大白兔皮膚/皮內刺激性試驗
ISO 10993-10 天竺鼠皮膚致敏性試驗
ISO 10993-11 急性全身毒性試驗/亞急性全身毒性試驗/亞慢性全身毒性試驗/慢性全身毒性試驗
ISO 10993-11 大白兔熱原試驗
ISO 10993-17 & ISO 10993-18 材料化學特性分析與毒理風險評估
萃取Extractable/溶出 Leachable 試驗評估
ICP/MS、LC/MS、GC/MS、FTIR等分析方法開發
毒理風險評估計算(NOAEL、LOAEL & MOS)

2. 醫療器械大動物功效性試驗(比格犬、迷你豬、羊、猴子)

3. 重複用醫療器械清潔確效及消毒驗證

4. ISO 18562 呼吸器產品測試方案規劃

生物相容性測試項目

・體外細胞毒性試驗
・致敏試驗
・皮膚刺激試驗
・皮內刺激試驗
・急性全身毒性試驗
・亞急性全身毒性試驗
・亞慢性全身毒性試驗
・慢性全身毒性試驗
・熱原試驗
・染色體畸變試驗
・骨髓微核試驗

・凝血試驗
・血小板粘附試驗
・補體激活試驗
・溶血試驗
・肌肉植入試驗
・皮下植入試驗
・骨植入試驗
・鼠傷寒沙門氏菌
・恢復突變試驗
・基因突變試驗
・血栓形成試驗

ISO 13485/GMP/GLP/GTP Quality System Consulting Service

Service Scope

  1. USFDA Quality System Regulation/ ISO 13485 Quality System consulting
  2. EU-MDD/MDR system consulting
  3. Taiwan FDA Medical device GMP system(Good Manufacture Practice) consulting
  4. Labratory ISO 17025 system consulting
  5. OECD- Good Laboratory Practice, OECD- GLP system conuslting
  6. Human Tissue Bank and GTP (Good Tissue Practice) consulting

Since ISO 13485:2016 announcment, medical device industry have to upgrade original quality system to compliance with 2016 version before 2019/2, Voler Biotech Consulting proivde fully training and consulting service to medical deivce industry and assisted our client got certification after certified body audited.

Our Consulting Service flowchart
1.Quality system planning stage- current situation analysis, target determination, international regulations compliance , medical industry specific standards, verification scope, establishment of enterprise organization specifications and authority structure.
2. System development stage-regulation training at all levels, related standard management and technical standards are implemented and records are established and pushed forward.
3.System builting stage-standard procedure builting , operation process and risk assessment management system planning and construction.
4.System implementation stage-internal audit and correction, management review and system operation, correction and integration.
5.System certification stage-external audit certification services and missing counseling; including formal certification login and continuous maintenance of the system.

Health food/ Neutriceutical product registeration consulting service

Health food registration service

According to th “HEALTH FOOD CONTROL ACT” which promulgated by TFDA, the term “Health Food” shall denote food with health care effects, having been labeled or advertised with such effects. The term “Health Care Effects” shall mean an effect that has been scientifically proven to be capable of improving people’s health, and decreasing the harms and risks of diseases. However, it is not a medical treatment aimed at treating or remedying human diseases.

Experimental design:Health care effect assessment, Stability test, Safety assessment, Sanitary specification test, Open package test, Excursion test, Disintegration/Brittleness test, Submission for Health Food Registration.

Assessment of health care effectAssessment of the regulation ability on hyperlipidemia, Assessment of the regulation ability on gastrointestinal functions, Assessment of the regulation ability on immunity, Assessment of the protection ability on damaged liver, Assessment of the regulation ability on obesity, Assessment of the regulation ability on allergy, Assessment of the protection ability on bone health, Assessment of the regulation ability on blood glucose, Assessment of the reduction ability on fatigue during exercise, Assessment of the regulation ability on anti-aging, Assessment of the protection ability on tooth, Assessment of the enhancement ability on iron absorption, Assessment of the regulation ability on blood pressure.

Consulting services: Submission for Health Food Registration, Application for non-traditional food ingredients, Customized scientific research, Consulting of governing food safety and sanitation, Professional experimental design and matching for testing institute.

服務內容

 

中國

  1. 國產 /進口醫療器械 中國註冊服務
  2. 中國 醫療器械動物試驗設計及臨床 豁免評估
  3. NMPA 中國醫療器械產品注册及可用性評估
    產品技術要求撰寫
    產品註冊檢驗追蹤
    產品註冊申報資料編寫
    註冊補充資料技術指導
    專家審評會組織協調
  4. NMPA 中國醫療器械臨床試驗
    臨床試驗方案及總結報告撰寫
    臨床試驗項目管理
    臨床試驗監察
    臨床試驗數據管理
    臨床試驗統計分析
    稽查及培訓
    臨床試驗數據採集分析系統
    臨床評價報告(CERCER)撰寫

Medical Device Regulation Service

Serivce Scope

 

USA FDA

The United States is the world’s largest single medical device market. At present, medical devices are managed by the US Food and Drug Association (USFDA). Voler Biotech Consulting Co., Ltd. has many years of FDA registration experience, and can assist client’s products in the listing, 510K and PMA registration of the FDA.
In addition to product registration services, we also have advanced consulting services to assist innovative products with FDA’s Q submission questions, which can improve the efficiency and risk of errors in the verification of innovative products.
In addition, we have experienced high-level consulting services in the establishment and inspection of FDA QSR 820 quality system. Let’s our client can successfully respond to FDA inspection audit.
1、FDA 510(k) submission(Medical Device & IVD)
2、PMA submision
3、De Novo submission
4、FDA Pre-submission Service
5、Product FDA Listing
6、Enterprise registeration in FDA

 

European

Medical devices register in the European Union need to obtain a CE mark before they can log into the European Union and establish a quality management system in accordance with the latest version of ISO13485. Voler Biotech Consulting Co., Ltd. provides complete services at all stages for CE certification of medical device, including ISO 13485 quality system certification planning and training. Assist customers to establish and meet the system certification requirements of various notify body; and provide guidance and assistance in the establishment of various technical requirements in the technical device files of products that comply with the MDD Directive (Medical Device Directive)
From 2020, the EU medical device management regulations will be completely changed to MDR regulations (Medical Device Regulation) to manage the medical device registration, certification, sales and post-market survellience within the EU. We can assist medical device manufacturers to obtain CE certification and ISO13485 compliance. Our services include the following:
1、EU Medical device CE mark consulting service
2、CE mark product techinical document follow ESPR(MDR) consulting
3、Qulaity system ISO 13485 consulting
4、Clinical Evaluation Report /Post market clinical follow(PMCF) and Post market Surveliience(PMS)
5、Euro Authorized Represntive(Euro ARep)registeration
6、SZUTEST Notified body CE certification(CE Mark 2195)
7、Compliance the latest MDR CE Mark regulation training

 

Taiwan,China,South Korea,India

Voler Biotech Consulting CO., Ltd. provides multi-national product registration services. Integrate international resources and rich experience to assist medical device manufacturers to register products in various countries.
1、Taiwan FDA class I/II/III product register
2、China NMPA medical device register include clinical trail study
3、Multi national product registeration