FDA 510 k Submission

Globe is recognized as FDA regulatory and compliance experts. Our engineering team incorporates FDA guidelines at the beginning of the design stage to reduce the failure rate in clinical trials. Globe can assist our customers in materials selection, label design, packaging, and sterilization. 

Globe has many years of experience in FDA 510K submission for drug delivery and safety medical devices. Our unique strengths are as follows:

  1. As a turnkey solution provider, we integrate the FDA guidelines during the beginning of the design and development phase. These guidelines include selection of medical grade material, sterilization method, clinical trial/sample size, functional testing method, etc.

  2. As design engineers, we organize and provide a design control master file as part of the FDA submission.

  3. As a product developer, we provide a customized quality assurance program that is validated.


Globe’s Regulatory Consulting solutions also include: 

I. Regulatory

1. FDA regulatory strategic planning
2. FDA Liaison / negotiation / conference
3. FDA submissions

II. Clinical Trial – Develop a protocol and testing method. 

III. Quality Systems/Manufacturing

1. cGMP
2. Quality training & audits

IV. International Service 

We also provide regulatory approval for the MOH (Ministry of Health) of Japan, China, Taiwan, Philippines,  and other countries. 

Our mission for regulatory approval is to help our clients develop efficient and effective quality systems in order to commercialize safe and efficacious products to meet quality and regulatory requirements.

Samples of US FDA, Japanese MOH (Ministry of Health and Welfare), and Russian MOH product regulation certificates:

Surgical Glove-FDA (510K) Clearance

 

  

 

 

 

 Burette Infusion Set-FDA (510K) Clearance

 

 

Blood Transfusion Set-FDA (510K) Clearance

 

 

IV, Burette, Needle Free-Japan Ministry of Health Certificate

Surgical Glove-Japan Ministry of Health Certificate

IV, Burette, Needle Free-Russian Ministry of Health Certificate

Surgical Glove-Russian Ministry of Health Certificate

IV Administration Set-FDA (510K) Clearance