FIRST CASE IN ! NEST lands another FDA 510K certification for disposable pen injector!-무석내사생명과학기술주식유한회사

Following the FDA 510(k) clearance of NEST Repeatable Pen Injector, NEST Disposable Pen Injector Landed U.S. Food and Drug Administration (FDA) 510(k) Letter!

K number: K240961

This is the first certificate in !

This is undoubtedly an important milestone in the domestic pen injector industry! This marks that NEST has a complete industrial chain of independent and controllable integrated service capabilities, and can provide high quality customization services!

NEST pen injector is a kind of injection device that combines medicine and injector into one, the medicine is placed in the pen in the form of a cartridge, and it is not necessary to extract the medicine(from a bottle) every time when using it, you only need to unplug the pen cap, and after adjusting the dose knob to the pre-set dosage, then you can carry out the injection of the relevant medicine.

NEST service scope covers from product design, process design, mold design and manufacturing, injection molding, surface treatment, irradiation sterilization and other independently controlled process. NEST also provides cartridge-related business with the technical characteristics of independent innovation and rapid product revitalization.

NEST has unique advantages in mold research and development, materials, project declaration, etc. In the stage of mold development and production, we use a variety of equipment to ensure the quality of the product and we put the “high quality” concept throughout the production process.

In the quality control of semi-finished products and finished products before release, NEST will carry out 4-batch testing to ensure the stability and consistency of product quality.

Free Fall Test

Trigger Force Test

Dose Adjustment Knob Stability Test

Appearance and Packaging Inspection

Based on years of continuous investment in research and development and business chain improvement, NEST can provide pen injector solutions according to customer's needs, plus high-performance automation solutions for high volume production in the pharmaceutical and healthcare industries.

Pen Injector Assembly Line

NEST's disposable pen injector & reusable pen injector have both obtained FDA 510(k), which represents another milestone step forward in the field of pharmaceutical packaging materials, and NEST's R&D and innovation capabilities have been internationally recognized, which will become the strongest quality assurance for NEST products.

In the future, NEST will still insist on R&D and innovation as the core of its strategy, continue to plough into the life science industry, and provide customers with more diversified and efficient integrated services.

U.S. FDA

Established in 1906, the U.S. Food and Drug Administration (FDA) is authorized by the U.S. Congress and is recognized as one of the largest food and drug regulatory agencies in the world. At present, through the U.S. FDA certified food, drugs, cosmetics and medical devices and other products, is recognized globally as effective on the human body and can ensure the safety of the product, is the product quality and effectiveness of the world's highest standard proof.

In the field of medical devices, the U.S. FDA certification has an extremely important role:

1. Objective review: The U.S. FDA monitors and audits medical devices on the market, and non-compliant products may be withdrawn or penalized. Obtaining FDA approval requires medical device manufacturers to submit a large number of product designs including clinical evaluations, risk management documents, and registration information, which the FDA reviews objectively, scientifically, and to a high standard. This rigorous review ensures that the safety and efficacy of the medical device is fully verified, and also reduces the risk of patients using the medical device.

2. International Recognition and Market Access: The U.S. FDA certification enjoys an excellent reputation worldwide, and many countries and regions regard the U.S. FDA certification as an important symbol of medical device safety and quality. Many hospitals, medical institutions and doctors also prefer to choose U.S. FDA-certified products when selecting devices. When a medical device manufacturer obtains U.S. FDA approval, it helps to build consumer trust in the product, and also leads to broader market access and greater sales opportunities.

3. Ongoing Supervision: Obtaining U.S. FDA approval is not the end of the road. After a manufacturer sells a medical device in the marketplace, the U.S. FDA will supervise the product in the marketplace to ensure the continued compliance of the medical device in long-term use.

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