Services

Enterprise internal training service

Cosmos Biomed has many years of experience in the medical device industry training service , and our rich regulatory experience can help medical device practitioners quickly grasp the update status of international regulations. We can help your new employee understand the life cycle of medical device products and the system structure of analytical quality. To help companies improve their international competitiveness, we welcome inquiries for internal training.

Training Scope

1. ISO 13456:2016 quality system management regulation introduction
2. Design control progress introduction
3. ISO 14971 Risk management of medical device training
4. Post market Surveillance introduction
5. Process validation practice training
6. Software validation practice training
7. Sterilization validation (Gamma/EO/Moisture heat sterilization) practice training
8. Product package validation practice training
9. ISO 10993 Biocompatibility evaluation under risk management process training
10. UDI Unique Device Identification System training
11. USFDA 510k submission practice training
12. European CE mark introduction and registration practice
13. QSR training and auditing key point practice
14. Taiwan FDA registration practice training
15. CE technical documentation and preparation practice training
16. Clinical evaluation documentation practice training

Sterilization validation service

Cosmos Biomed has established strategic partnerships with China’s internationally certified EO Sterilization Service Facility to provide a comprehensive EO sterilization validation plan to improve the quality of medical device customers and the safety of consumer use. We bring together senior sterilization specialists and ISO 17025 accredited microbiology laboratories to assist you achieve a complete sterilization validation report to keep your product safe and meet international standards.

Service Portfolio

 

EO Sterilization validation study and EO Sterilization service

Introduction of EO gas

  1. EO can be used for sterilization of temperature and moisture sensitive items
  2. It is considered to be the best chemical sterilization agent for sterilization, killing all microorganisms (including bacterial spores)
  3. EO has strong penetrability, can be used for sterilization of various difficult-to-penetrate parts (such as some thinner, longer catheters).It is difficult to achieve sterilization with other low temperature sterilization methods. Only EO or irradiation can be used.
  4. EO damage to the item is minor, because EO kills microorganisms by using the principle of alkylation instead of oxidation. Therefore, it has a very wide range of uses for the sterilization of heat-resistant precision instruments.
  5. When sterilizing, it can be wrapped with permeable and impervious packaging materials, which is convenient for storage, transportation and opening the package.
    Use to avoid the risk of cross contamination.
  6. Sterilization method is low-cost, easy to monitor, suitable for most medical grade plastics, requires a long week to eliminate the EO/ECH residue.

Introduce of Bioburden

What is Bioburden?
The total number of microorganisms that survived the detection of unsterilized medical device products that have been packaged, or defined as population of viable microorganisms on or in product and/or sterile barrier system

Why mandatory to perform “Bioburden Test”?
According to the bioburden of the device, it can be decided sterilization parameter

Sterility test

Purpose
In order to assure the sterilization effectiveness of sterilized medical device products, refer to the US Pharmacopoeia USP-30<71> and ISO 11737.

Scope
The test method is applicable to the sterility test of the medical device product after sterilization; the main purpose of the method and the result thereof is to assist the sterilization effect of the product and increase the confidence level of the routine sterilization batch quality assurance, and it is not recommended to use the routine sterilization batch separately. The release is not repeated to ensure that the products in the batch are completely sterilized or sterilized.

Sterility check
Sterility tests include microfiltration membrane filtration and direct inoculation. When performing sterility inspection of the product, the method a condition used shall be the same as the verification method

EO sterilization residue test

According to ISO10993-7 Biological evaluation of medical devices —Part 7: Ethyleneoxide sterilization residuals method, the residue analysis and estimate the criteria by device contact period with ISO 10993-1.

OECD GLP certified medical device biocompatibility testing

Cosmos Biomed has an international OECD GLP certified laboratory. The safety and effectiveness of medical devices is the major goal of product certification. Medical devices that normally contact with the human body follow ISO 10993 international standard for safety risk assessment to ensure that the products passed pre-market approval. Into the request. We bring together experienced veterinarians and technical expertise in the companies. Our OECD GLP report widely acceptable by worldwide government submission.

We are convinced that service is not just a trust, but a responsibility for the rigorous control of products. Through professional test plan design, you can correctly screen the product materials or process the risk of possible risk. The test efficiency is our commitment to your service.

Service Portfolio

 

1. ISO 10993 and GB/T 16886 biocompatibility study plan consulting

ISO 10993-1 Biocompatibility evaluation plan consulting under risk management process
ISO 10993-3 Genotoxicity study ( AMES test: Salmonella Typhimurium Reverse Mutation Test OECD 471 /In Vitro Mammalian Cell (TK+/- cell ) gene mutation test OECD 490/ In Vitro mammalian cell chromosome aberration test OECD 473/ In Vivo mouse peripheral blood micronucleus test OECD 474)
ISO 10993-4 Hemocompatibility tests (Hemolysis test/ In-vivo Thrombogenicity in Dog/ Complement Activation – C3a, SC5b-9/ Platelet aggregation/ Partial Thromboplastin time (PTT)/ In Vitro Hemocompatibility (IVH, Complete Blood Count)
ISO 10993-5 In Vitro Cytotoxicity test (L929, 3T3, V79 cell lines)
ISO 10993-6 Muscle implantation test
ISO 10993-6 Subcutaneous implantation test
ISO 10993-6 Bone implantation test
ISO 10993-10 Rabbit skin/intracutaneous irritation test
ISO 10993-10 Skin sensitization test (Kligman Guinea Pig Maximization Test (GPMT) / Close patch)
ISO 10993-11
Acute systemic toxicity / Subacute systemic toxicity/Subchronic toxicity /Chronic systemic toxicity
ISO 10993-11 Pyrogen test
ISO 10993-17& ISO 10993-18 Chemical characteristic analysis and toxicological risk assessment
Extractable and leachable test evaluation
ICP/MS, LC/MS, GC/MS, FTIR method validation
Toxicological risk estimation (NOAEL, LOAEL & MOS, AET)
Biocompatibility Evaluation Plan and Report (BEP&BER)

2. Medical device animal performance functional study( Beagle, mini pig, goat/sheep, Monkey)

3. Reusable medical device cleaning and disinfection reprocess validation

4. ISO 18562 air flow pathway device testing

Biocompatibility Test

・In Vitro Cytotoxicity Test
・Skin Sensitization Test
・Skin Irritation Test
・Intracutaneous Test
・Acute Systemic Test
・Sub-acute Toxicity Test
・Sub-chronic Toxicity Test
・Chronic Toxicity Test
・Pyrogen Test
・Chromosome Aberration Test
・In Vivo Bone Micronucleus Test

・Hemocompatibility: Partial Thromboplastin Time (PTT)
・Hemocompatibility: Platelets
・Hemocompatibility: Complement Activation, SC5b-9
・Hemolysis Test
・Muscle Implantation Test
・Subcutaneous Implantation Test
・Bone Implantation Test
・Genotoxicity: Ames Test
・In Vitro Mammalian Cell Gene Mutation Test (TK Test)
・Hemocompatibility: Dog Thrombogenicity

Quality system consulting service

The quality system of the manufacturer is the threshold for entering the medical device field. Cosmos Biomed has many experts whose years of experience in the quality assurance department of the medical device industry and the former international verification company. With the coming of the MDD and MDR , we will greet you with you n the new version of the regulatory requirements to assist you complete the quality system audit, check your products.

Service Portfolio

  1. China NMPA quality system consulting service
  2. USA QSR / CE ISO 13485 quality system consulting service
  3. EU medical device MDD/MDR transfer consulting service
  4. Taiwan GMP quality system consulting service

CHINA NATIONAL MEDICAL PRODUCTS ADMINISTRATION(NMPA)MEDICAL DEVICE REGISTRATION SERVICE

Cosmos Biomed has established a long-term strategic partnership with China local CRO. The differentiation of China’s NMPA registration process and international regulations has been deterred by manufacturers in various countries. We hope to break the lengthy application time, and the well-planned test consultants and experienced China regulation enforcement teams will jointly plan and perfect the evidence collection plan. Through transparent and compliance suggestions, customers will be able to grasp the evidence and test dynamics in real time. Clinical trial planning and clinical trial exemption assessment are our strengths. Smooth communication is our advantage. Through our consulting services, you can confidently expand the Greater China market and establish a foothold in Asia.

Service Portfolio

 

CHINA NMPA

  1. Local/Import medical device China NMPA registration
  2. China Medical device Animal study planning and clinical trial exemption
  3. China NMPA medical device registration and usability evaluation
    Device technical requirement consulting service
    Device registration testing follow up service
    Device registration documentation and writing service
    Device gap compensation consulting service
    Expert review committee communication
  4. China NMPA clinical trial studying service
    Clinical trial protocol and report medical writing
    Clinical trial management
    Clinical trial monitoring
    Clinical trial data management
    Clinical trial statistical analysis
    Auditing and training program
    Clinical trial data sampling analytic system
    Clinical evaluation report writing

Global medical device registration service

Cosmos Biomed provides the best bridge for medical device companies to enter overseas markets. Our Asian consultant team has many years of experience in international regulations, freeing language barriers and providing online consulting services, and promptly assisting clients in obtaining evidence is our goal. No matter which country you choose to sell, we offer a complete one-stop solution to accelerate your access to the international marketplace through years of regulatory and forensic experience.

Service Portfolio

 

USA

FDA 510K submission (MD % IVD)
Pre market approval application
De Novo submission
FDA Pre-submission Service
FDA Listing

 

European Union CE mark

1. European Union Medical device MDD/ MDR CE mark consulting
2. CE technical file establishment and assessment consulting
3. The latest Quality system ISO 13485 consulting
4. Clinical evaluation report consulting (CER) / Post -market Surveillance (PMS) and Post market clinical follow up (PMCF) consulting
5. Euro Rep registration

 

Taiwan、Korea、India

1. Taiwan FDA Medical device registration class I/II/III and QSD application
2. Korea KFDA/ India medical device registration