Medical devices-how to verify the packaging of active products

How to verify the packaging of medical devices-most active products are calculated from the factory date, that is, the final packaging date, but in fact they should be calculated from sterilization. Let's give the simplest example. For example, the sterilization date of a bread is 20 10 1 (of course, you don't know when it was sterilized), and its production date, that is, the last packaging date, is 2010/.5, and its validity period is 6 months. Then, its validity period is from 20 10 1.5 to June 4, 20 10, which is the validity period of this bread. You must ask, there will be five days between 20 10, 1, 1. If the validity period is six months, then 20 10 has expired on June 5 and cannot be eaten. You know, when they make bread, the amount of some molds will not be specific to just a few days, just like you found that the bread is still edible after June 4, 20 10. In fact, all products are almost the same procedure and will not deteriorate in just a few days (except, of course, the shelf life is only a few days). The reason why he has a shelf life is that in case of any quality problems, the manufacturer will have a responsible time period. It is impossible to say that the bread is bad after three years. If you go to the manufacturer, the manufacturer is still responsible. The date you mentioned when picking went into production is another matter. For example, making bread requires cream and flour, which is the shelf life of flour and cream. They are made into bread after baking, and they change from one ingredient to another. The expiration date cannot be calculated according to the original date. But for example, the shelf life of cream, if the shelf life of bread is 6 months, then the cream for making bread must be stored for about 6 months, because you have to leave it for a while before making bread, right?

How to define medical devices-active products? The popular understanding is that it is active products that need live working.

How to obtain CE certification for medical device products? Medical device certification

SNCH, a joint announcement organization of Topmen, provides comprehensive medical device product certification services for domestic enterprises, enabling enterprises to meet the requirements of EU ce. We will make full use of our international platform to provide more comprehensive services for medical device enterprises.

We adopt different certification modes to provide certification services for manufacturers of different medical device products, including:

1. Product classification judgment

2. Enterprise technical documentation assistance

3. Enterprise management support and assistance

4. Product testing

5. Factory audit (if applicable)

6.CE certificate issuance

background

1. A global multinational enterprise headquartered in the UK; It has offices in 56 countries and more than 30,000 registered customers.

2. Asia-Pacific headquarters is located in Shanghai, providing customers with fast, professional and trustworthy services;

3. Technical experts have long participated in the research and formulation of European regulations, and have decades of experience in product and system certification, providing customers with one-stop solutions;

4. Certified products involve all kinds of medical devices, with more than 300 certified customers;

5. Open and fair certification service process to ensure the whole process of customer monitoring.

Testing and auditing

At present, we have localized testing and auditing, that is, all testing and auditing will be conducted in China, with domestic staff, which can save the cost and testing cycle of enterprises.

How to be a medical device agent is relatively simple. Generally speaking, there are requirements for acting as an agent, depending on what channels you sell. Offline is different from online.

How to be a good medical device brand agent? Medical device agents, regular manufacturers like Shandong Mingtai, generally require:

The licenses are complete and the annual inspection is normal (business license, tax registration certificate, organization code certificate, business license, etc.). );

The company has a certain strength, (this is very important, now many manufacturers are engaged in distribution, you can do several hospitals to authorize several hospitals to do it for you)

Have a certain understanding of the local bidding office, and can play a public relations role to help manufacturers win the bid when bidding again.

Recognize the products, prices and values of production enterprises.

As for the contract, the manufacturer has a fixed template, but the price, province, city and number of agents have all been modified to a certain extent, and nothing else will change (this answer is taken from the recommendation of experts in science education classification)

What is the verification method of medical device products? If it is in a laboratory, it may be a simulated environment of instruments and equipment.

If animals and humans must be used for clinical trials in the end.

Aozida medical equipment consultation organization

How to do clinical trials of medical devices? The clinical trial (verification) of medical devices should be no less than the clinical trial of drugs in terms of its scope and complexity, because the products covered by medical devices are far more than drugs, and the common ones are therapeutic, supportive, substitutive, diagnostic, inspection and analysis. The clinical trial and verification requirements of different types of products are obviously different. If there are ISO or CE standards for general medical devices, their standards will include the requirements of clinical trials; Therefore, we can refer to ISO or CE standards when conducting clinical trials. Domestic laws and regulations mainly consider OrderNo. 16 and Order No.5, and there is no document similar to the Guiding Principles for Clinical Research of New Drugs. All of them are based on specific products and refer to the clinical literature of similar listed varieties. Of course, they need to be determined with the researchers. Personal suggestion is to consider the clinical scheme from the perspective of registered product standards. The technical requirements in the registered product standards can be clinically verified, and it is best to have clinical data; Another important aspect is safety evaluation, and its principles should be unified. Statistical analysis of the incidence of adverse events can explain most problems. As far as the requirements of medical device registration and clinic in China are concerned, finding CRO is not the first choice. It should not be too difficult to find suitable units and experts to deal with the registration review.

Searching for hospitals with clinical qualifications in China is completed by hospitals, and enterprises need to provide corresponding test samples and sign contracts.

How to represent medical device products? Looking for equipment is an online shopping mall for B2B procurement and wholesale of medical equipment, which is established and operated by Baden Medical Co., Ltd.!

Provide self-operated+matchmaking services for buyers and sellers in the medical device industry! Quickly aggregate more than 2,000 high-quality merchants, tens of thousands of medical device distributors and hospital resources in an efficient way through the Internet.

Excuse me, what should I do to verify the CE certification packaging of medical devices? SNCH, a joint announcement organization of Topmen, provides comprehensive medical device product certification services for domestic enterprises, enabling enterprises to meet the requirements of EU ce. We will make full use of our international platform to provide more comprehensive services for medical device enterprises. We adopt different certification modes to provide certification services for manufacturers of different medical device products, including: