Medical Devices Analysis

From common medical supplies (infusion bags, injections, aerosols, etc.) to complex instruments (heart valves, artificial pancreas) that help save and sustain life, medical devices play vital roles in the treatment and diagnosis of illnesses and diseases. Although medical devices provide great benefits to patients, they also present risks. FDA's current Good Manufacturing Practices (GMP) requires that any domestic or foreign manufacturer establish a complete set of quality system to ensure the medical devices comply with the inspection standards in areas of design, manufacture, packaging, labeling, storage, installation and maintenance. For both manufacturers and consumers, it's important to protect patients and promote public health. FDA's public health responsibilities span the life cycle of medical devices at every stage. Alfa Chemistry offers validated extractable and leachable (a.k.a. E&L) studies which are used to test medical devices to ensure the packaging will not leach out harmful chemicals during its storage and use.

E&L analysis services at Alfa Chemistry include:

• Label migration studies

• Packaging safety & Toxicity analysis

• Controlled extraction studies for raw material control

• Food contact notification & Migration studies

Medical devices analysis at Alfa Chemistry follows quality system inspection standards:

• Quality System (QS) Regulations of the FDA's current Good Manufacturing Practices (GMP)

• Active Implanted Medical Devices Directive (AIMD, Council Directive 90/385/EEC)

• Medical Device Directive (MDD, Council Directive 93/42/EEC)

• In vitro Diagnostic Medical Device Directive (IVDD, Council Directive 98/79/EEC)

The purpose of medical devices analysis:

Quality inspection of medical devices can help eliminate hidden dangers in the use of devices, reduce the possibility of medical accidents, detect product failures in time, and resolve them as soon as possible to reduce costs.

Alfa Chemistry offers medical devices analysis for:

• Disposable syringes

• Infusion sets

• Nursing finger covers

• Sterile cotton swabs

• Surgical gowns

• Injection needles

• Acupuncture needles

• Other common medical devices

Equipment for the analysis and identification of medical devices at Alfa Chemistry :

Main features of at Alfa Chemistry :

• Professional

With strict testing standards, perfect testing tools, professional inspection personnel and complete inspection reports, Alfa Chemistry can provide you the most professional medical devices analysis services ever possible.

• Economical

It helps to reduce the maintenance costs and maximize the benefits of the medical devices.

Alfa Chemistry will provide professional analysis reports and effective communication. When you contact us for medical devices analysis services, you'll be connected to a team of dedicated staff who can answer your questions that allows your product to meet all regulatory requirements. Please feel free to contact us at any time.