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Medical Device Establishment Registration Articles & Analysis
23 news found
Obtaining the Marketing Authorisation Application (MAA) is a key step in the commercialization of drugs in the EU, and also an important help to promote the global market expansion of pharmaceutical companies. The MAA is complicated by the need to consider both European economic integration and the independence of individual member states. As a specialist in regulatory matters, Proregulations has ...
U.S. medical device regulations require manufacturers of most class II and a small number of class I devices to file a 510(k) unless they qualify for an exemption. 510(k) is a premarket technical document submitted by the manufacturer to the FDA before the medical device product enters the US market to prove that the product has the same safety and effectiveness in terms of intended use, design, ...
Proregulations has emphasized and thoroughly researched the U.S. cosmetic regulations, and has compiled the following highlights: Registration Number Application The FDA Establishment Identifier (FEI) is an FDA system-generated number used to identify a company. ...
An Abbreviated New Drug Application (ANDA) is an application submitted to the U.S. FDA to demonstrate that a generic drug is equivalent to a previously approved Reference Listed Drug (RLD) in terms of safety, efficacy, and quality. The ANDA contains information used for the review and approval of a generic drug product, and does not typically require preclinical and clinical trial data, but ...
To sum up, Proregulations can offer support in activities like FDA Medical Device Registration, 510(k) Premarket Notification, Drug Master File Document, FDA ANDA, FDA NDA, FDA Cosmetics Registration, New Dietary Ingredients Compliance, Toxic Substances Control Act Compliance, FDA Agent Services, Medical ...
CardioWise, Inc., is pleased to announce that Perry Johnson Registrars, Incorporated has audited the CardioWise Quality Management System (QMS) and determined CardioWise is in conformance with ISO 13485:2016. Perry Johnson Registrars Certificate C2022-02910 was issued July 16, 2022, and represents the first step in the process of obtaining a CE mark and Medical Device Registration for the ...
EchoPixel’s True3D software platform, a pre-operative planning technology that creates a hologram of the heart for study before an incision is ever made, has received PMDA Medical Device Registration and Approval in Japan. This first-of-its-kind software enables the entire heart surgical team to develop a precise personalized plan by interacting with specific organs and tissues as if ...
Digitsole, a leader in the digital health space bringing together digital mobility biomarkers and biomechanical data with clinical expertise, has received Class II medical device registration with the U.S. Food and Drug Administration (FDA) for its Digitsole Pro® smart insoles. Digitsole Pro®, recently launched in the United States, is a solution, developed with, and for ...
NanoPin Technologies (New Orleans, Louisiana, USA) announces the establishment of a strategic partnership with Shanghai Reigncom Biotechnology Co., Ltd. ...
Recently the state food and drug supervision and administration bureau released five related medical devices regulations come into force as of June this year to the new revision of the regulations on the supervision and administration of medical devices, authorized by the state administration of the in-depth research, many times, on the basis of demonstration, solicit opinions from all sides, and ...
Transluminal Technologies has been assessed and approved by BSI Group America against the provisions of ISO 13485:2003. Successful registration assures the firm’s quality management systems comply with requirements established by the International Organization for Standardization (ISO). ISO 13485:2003 is an internationally recognized quality standard ...
Food and Drug Administration (FDA) medical device and product approval, registration and data compensation arbitrations, chemical product litigation, and associated business counseling and litigation issues. B&C's clients are involved in many businesses, including conventional, biobased, and nanoscale basic, specialty, and agricultural and ...
Food and Drug Administration (FDA) medical device and product approval, registration and data compensation arbitrations, chemical product litigation, and associated business counseling and litigation issues. B&C's clients are involved in many businesses, including conventional, biobased, and nanoscale basic, specialty, and agricultural and ...
Food and Drug Administration (FDA) medical device and product approval, registration and data compensation arbitrations, chemical product litigation, and associated business counseling and litigation issues. B&C's clients are involved in many businesses, including conventional and nanoscale basic, specialty, and agricultural and antimicrobial ...
Plamondon will speak in Las Vegas, Nevada, at the 30th Biennial Western Coatings Symposium on the regulation of polymers under the Toxic Substances Control Act (TSCA), the European Union's Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, and the Canadian Environmental Protection Act (CEPA). ...
Food and Drug Administration (FDA) medical device and product approval, registration and data compensation arbitrations, chemical product litigation, and associated business counseling and litigation issues. B&C's clients are involved in many businesses, including conventional and nanoscale basic, specialty, and agricultural and antimicrobial ...
Food and Drug Administration (FDA) medical device and product approval, registration and data compensation arbitrations, chemical product litigation, and associated business counseling and litigation issues. B&C's clients are involved in many businesses, including conventional and nanoscale basic, specialty, and agricultural and antimicrobial ...
This is an internationally recognized standard of quality management for the design and manufacture of medical devices. "This is just the latest step that Agilent has taken to clear the way for use of our life science tools in the clinic," said Gustavo Salem, Agilent vice president and general manager, Biological Systems Division. ...
. -- Located in Washington, D.C., B&C is a law firm focusing on conventional and nanoscale industrial, agricultural, and specialty chemical product regulation and approval matters, medical device and product approval, registration and data compensation arbitrations, chemical product litigation, and associated business counseling and ...
. -- Located in Washington, D.C., B&C is a law firm focusing on conventional and nanoscale industrial, agricultural, and specialty chemical product regulation and approval matters, medical device and product approval, registration and data compensation arbitrations, chemical product litigation, and associated business counseling and ...