Through our global network of testing experts and analytical equipment including chromatography (HPLC, GC, GC/MS) and atomic
absorption spectroscopy (AAS, GFA, FIAS), Our goal is to provide test services as efficiently
as possible to maximize our customers' profits. For more information about our services,
contact one of our experts today.
Note: this service is for Research Use Only and Not intended for clinical use.
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 :
Equipment
Test
TDK half-wave darkroom TDK all-electric darkroom
Radiated immunity
RF signal source power amplifier)
Conducted immunity
High and low temperature humidity test chamber
High and low temperature test Constant damp heat test Alternating damp heat test
High temperature aging room
High temperature test
Zero Drop Bench
Fall test
Intelligent salt spray corrosion test box
Salt spray test
Electromagnetic vibration table
Sine sweep vibration Sinusoidal fixed frequency vibration Random vibration
Aerodynamic Impact Test Bench
Impact test
Collision test stand
Collision test
Waterproof tester
Waterproof test
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.