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Experienced researchers and technicians are at your service when you partner with American Preclinical Services. You gain one-stop access to full biocompatibility, interventional, and surgical research and pathology services within a world-class facility. ISO 17025 accredited, AAALAC accredited, USDA licensed, and GLP compliant, American Preclinical Services offers you the bundled resources you require to achieve rigorous medical device testing in a single laboratory operation.

Share on Google+ March 13, 2018

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APS Adds Capacity, Capabilities, and Competencies to its Research Campus

Category : APS Service Offerings

American Preclinical Services (APS) is proud to announce the addition of a new cath lab, 25,000 sq ft of new laboratory space, 11,000 sq ft of new large animal housing capacity and a new Director of Toxicology. Located within the APS research campus, the new laboratory space will include a 7,000 sq ft analytical lab, a 5,000 sq ft in-vitro

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Share on Google+ March 12, 2018

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Medical Device Innovation: Dealing with Challenges

Category : Medical Device testing

Event Date and Time Thursday, April 12th, 2018 4:30 PM – 7:30 PM CST Location American Preclinical Services 9055 Evergreen Boulevard Coon Rapids, MN 55433  Description Cost: FREE         Join APS and Medical Alley for a night of networking and discussions surrounding medical device innovation. Three industry professionals will provide insights into dealing with challenges seen during

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Share on Google+ January 19, 2018

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APS Regulatory Update: FDA Delays UDI Enforcement for Class I and Unclassified Devices

Category : FDA, Regulatory

US FDA has pushed back enforcement of unique device identification (UDI) compliance deadlines for some low-risk (Class I and Unclassified) medical devices by at least two years.  Table 1 below provides the compliance dates. Table 1: Compliance Dates for Class I and Unclassified Devices   Type of Device FDA does not intend to enforce UDI labeling (21 CFR 801.20 &

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Share on Google+ October 30, 2017

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FDA Finalizes 510(k) Guidances on When to Submit a New 510(k)

Category : FDA, Medical Device testing, Regulatory

On October 25, 2017, the FDA released two final guidance documents: “Deciding When to Submit a 510(k) for a Change to an Existing Device,” which applies to medical device changes broadly, and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device,” which focuses on software-specific changes and complements the broader guidance document.  These guidance documents

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Share on Google+ September 18, 2017

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FDA’s plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework

Category : FDA

On 07 September, 2017, FDA announced its plan to engage the public in the agency’s new effort to strengthen and modernize FDA’s regulatory framework. FDA’s goal is to ensure that its policies and regulations keep pace with the challenges encountered in protecting consumers, and the opportunities to improve lives. This new effort includes areas where FDA’s rules concerning new drugs

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Share on Google+ September 11, 2017

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Strengthening EU-US cooperation in medicine inspections

Category : FDA

New commitment allows FDA to share full inspection reports with European Commission and EMA The European Commission (EC), the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment that allows the US regulator to share non-public and commercially confidential information, including trade secret information relating to medicine inspections with

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