Quality management system

U.S. Propulsion Leader Ursa Major Achieves AS9100D Certification

Retrieved on:

Wednesday, December 6, 2023

Federal Aviation Administration, Aviation, Ursa Major, Ursa Major Technologies, Growth, Certification, NASA, Quality management system

DENVER, Dec. 6, 2023 /PRNewswire/ -- Ursa Major, America's leading privately funded company focused solely on rocket propulsion, announces successful completion of AS9100D certification with TUV Rheinland of North America.

Key Points:

With AS9100D Certification, Ursa Major demonstrates a Quality Management System ready to meet propulsion demand across the defense and aerospace industry.
DENVER, Dec. 6, 2023 /PRNewswire/ -- Ursa Major, America's leading privately funded company focused solely on rocket propulsion, announces successful completion of AS9100D certification with TUV Rheinland of North America.
"As the only independent AS9100D certified propulsion company, Ursa Major continues to prove itself as the leading propulsion team in the country, providing reliable, safe, and easily acquired products of the highest quality," said Joe Laurienti, Ursa Major Founder and CEO.
"Certification to AS9100D not only confirms Ursa Major as a trustworthy supplier, but also provides customers with our commitment to continual improvement."

3-Hour Virtual Seminar on Computer System Validation (CSV) vs. Computer Software Assurance (CSA): Learn About FDA's Approach to Modernizing Technology, and Benefits for Both the Agency and Industry

Retrieved on:

Wednesday, November 22, 2023

A key element is a risk-based, product quality and patient-centric approach to Computer System Assurance (CSA) vs. the traditional Computer System Validation (CSV) Waterfall approach.

Key Points:

A key element is a risk-based, product quality and patient-centric approach to Computer System Assurance (CSA) vs. the traditional Computer System Validation (CSV) Waterfall approach.
The attendee will learn about FDA's approach to modernizing technology, and how that will benefit both the Agency and industry.
This approach is amenable to the Agile software development methodology, which can be adapted for use in validation.
She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

Medcrypt Appoints Naomi Schwartz as Vice President of Services, Emphasizing FDA Readiness Services for Medical Device Manufacturers

Retrieved on:

Tuesday, November 21, 2023

Organization, SAN, Food, MDM, US Foods, FDA, QMS, Computer security, Teaching, Quality management system, Knowledge, Management control system, Letter, Environment, Pharmaceutical industry, Medical device, Risk management

SAN DIEGO, Nov. 21, 2023 /PRNewswire/ -- Medcrypt, Inc., the proactive cybersecurity solution provider for medical device manufacturers (MDMs), today announced the promotion of Naomi Schwartz to Vice President of Services. In this new role, Naomi will harness her extensive knowledge of FDA interactions and regulatory compliance to provide exceptional guidance to clients, ultimately helping critical, lifesaving devices meet the FDA's guidelines and gain approval faster.

Key Points:

"The urgency for prioritizing cybersecurity has never been more pressing and many organizations are struggling to position themselves strategically to derive tangible business value from this imperative shift," said Naomi Schwartz, MedCrypt's Vice President of Services.
"I'm eager to step into this VP role at Medcrypt to guide our customers toward success in the evolving landscape of medical device clearance and approvals.
"Our commitment to delivering top-tier services is driven by our desire to bridge the education gap in medical device cybersecurity.
For more information on Medcrypt's services and the latest developments in medical device cybersecurity, please visit www.medcrypt.co .

SDP/SI Passes Recertification AS9100 and ISO 9001 Quality Management System Audit

Retrieved on:

Thursday, November 9, 2023

Quality management system, Documentation, Aviation, Intertek, AS, ISO, QMS, Medical device, Audit

HICKSVILLE, N.Y., Nov. 9, 2023 /PRNewswire-PRWeb/ -- Stock Drive Products/Sterling Instrument (SDP/SI), a Designatronics, Inc. company, completed and passed its recertification AS9100:D and ISO 9001:2015 quality system audit. The audit, conducted by Intertek over a 5-day period, certifies SDP/SI's quality management system conforms to AS and ISO standards.

Key Points:

SDP/SI completed and passed its recertification AS9100:D and ISO 9001:2015 quality system audit.
HICKSVILLE, N.Y., Nov. 9, 2023 /PRNewswire-PRWeb/ -- Stock Drive Products/Sterling Instrument (SDP/SI), a Designatronics, Inc. company, completed and passed its recertification AS9100:D and ISO 9001:2015 quality system audit.
The audit, conducted by Intertek over a 5-day period, certifies SDP/SI's quality management system conforms to AS and ISO standards.
The in-depth AS and ISO recertification audit takes place every three years and is performed by an unbiased third party.

SINTX TECHNOLOGIES ENTERS A LONG-TERM SUPPLY AGREEMENT FOR AEROSPACE COMPONENTS

Retrieved on:

Tuesday, November 7, 2023

Quality management system, LTA, SALT, Silicon, 3D printing

SALT LAKE CITY, Nov. 07, 2023 (GLOBE NEWSWIRE) -- SINTX Technologies, Inc. ( www.sintx.com ) (NASDAQ: SINT; “SINTX” or the “Company”), a manufacturer and developer of advanced ceramic materials and related technologies, announced that it has entered a Long-Term Agreement (LTA) to supply jet engine components made of its silicon nitride.

Key Points:

SALT LAKE CITY, Nov. 07, 2023 (GLOBE NEWSWIRE) -- SINTX Technologies, Inc. ( www.sintx.com ) (NASDAQ: SINT; “SINTX” or the “Company”), a manufacturer and developer of advanced ceramic materials and related technologies, announced that it has entered a Long-Term Agreement (LTA) to supply jet engine components made of its silicon nitride.
The agreement materialized after a rigorous 2-year qualification of the Company’s Operational and Quality Management Systems and manufacturing capabilities, and successful testing of prototype components.
“To meet the challenge of making aerospace parts with complex designs, SINTX had to innovate new manufacturing capabilities and processes,” said Dave O’Brien, Executive Vice President and Chief Operating Officer at SINTX.
The LTA allows SINTX to fulfill all of the customer’s requirements for silicon nitride aerospace components as long as SINTX meets specified quality, delivery, and purchase order metrics.

Synopsys Expands Its ARC Processor IP Portfolio with New RISC-V Family

Retrieved on:

Tuesday, November 7, 2023

SUNNYVALE, Calif., Nov. 7, 2023 /PRNewswire/ -- Synopsys, Inc. (Nasdaq: SNPS) today announced it has extended its ARC® Processor IP portfolio to include new RISC-V ARC-V™ Processor IP, enabling customers to choose from a broad range of flexible, extensible processor options that deliver optimal power-performance efficiency for their target applications. Synopsys leveraged decades of processor IP and software development toolkit experience to develop the new ARC-V Processor IP that is built on the proven microarchitecture of Synopsys' existing ARC Processors, with the added benefit of the expanding RISC-V software ecosystem.

Key Points:

Proven and mature Synopsys MetaWare software development toolchain enables programmers to create highly optimized code for Synopsys ARC-V Processor IP.
(Nasdaq: SNPS ) today announced it has extended its ARC® Processor IP portfolio to include new RISC-V ARC-V™ Processor IP , enabling customers to choose from a broad range of flexible, extensible processor options that deliver optimal power-performance efficiency for their target applications.
Synopsys leveraged decades of processor IP and software development toolkit experience to develop the new ARC-V Processor IP that is built on the proven microarchitecture of Synopsys' existing ARC Processors, with the added benefit of the expanding RISC-V software ecosystem.
The 32-bit Synopsys ARC-V RHX real-time processor IP and 64-bit Synopsys ARC-V RPX host processor IP are scheduled to be available in the second half of 2024.

Calibre Intercepts High-Grade Gold Below the Jabali Mine and Resource and Identifies Three Additional Gold Targets All Within 10 km of the Libertad Mill; Initial Jabali Results Include 10.80 g/t Gold Over 14.3 Metres and 8.44 g/t Gold Over 8.9 Metres

Retrieved on:

Tuesday, October 31, 2023

High-grade gold from underground drilling, approximately 100 metres below the main Jabali resource, confirms mineralization and continuity down-dip with strong potential for resource expansion.

Key Points:

High-grade gold from underground drilling, approximately 100 metres below the main Jabali resource, confirms mineralization and continuity down-dip with strong potential for resource expansion.
Additionally, scout level drilling across the property has identified three new target areas located within 10 km of the Libertad mill.
First pass results shown in the Figures linked below demonstrate the potential for additional, near surface gold resources.
Initial drill results, along the same trend as the recently announced Volcan open pit resource, demonstrate strong potential to expand resources and discover new zones.

Microbot Medical Received Confirmation for the Commencement of Its CE Mark Approval Process During the First Half of 2024

Retrieved on:

Tuesday, October 24, 2023

Quality management system, FDA, ZEUS robotic surgical system, MDR, Certification, QMS, European, CE marking, ISO, Medical device

BRAINTREE, Mass., Oct. 24, 2023 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Robotic Surgical System, today announces it has received confirmation for the commencement of the process to support its future CE Mark approval, and to ultimately allow the Company to market the LIBERTY® Robotic Surgical System in Europe as well as other regions who accept the CE Mark.

Key Points:

According to the confirmation, the Company will commence audits for ISO 13485 certification to ensure its compliance with the Quality Management System (QMS) requirements of the EU Medical Devices Regulation (MDR 2017/745), during the first half of 2024.
The Company had previously taken the first step to advance its European program by engaging with a leading Notified Body, who recently confirmed dates for conducting the required audits.
The audits for Microbot’s ISO 13485 certification will incorporate an off-site audit that includes a review of the Company’s quality system and the LIBERTY® Robotic Surgical System Technical File, followed by an on-site audit at the Company’s facilities.
“We intend that this process will be conducted in parallel with our FDA approval efforts, to allow us to capture as many markets across the globe as we prepare for future commercialization.”

Neoss® Group receives EU Medical Device Regulation (MDR) certifications for implants and abutments

Retrieved on:

Thursday, October 12, 2023

European, Certification, BSI Group, Legislation, MDR, Database, Regulation, Quality management system, Notified body, Netherlands, BSI, MDD, European Medical Devices Industry Group, Patient, Medical device, EU

ZÜRICH, Oct. 12, 2023 /PRNewswire/ -- Neoss Group, a leading innovator in dental implant solutions, is proud to announce that it has received EU Medical Device Regulation (MDR) certification by its Notified Body, the BSI Group, the Netherlands B.V. for its implants and abutments.

Key Points:

ZÜRICH, Oct. 12, 2023 /PRNewswire/ -- Neoss Group, a leading innovator in dental implant solutions, is proud to announce that it has received EU Medical Device Regulation (MDR) certification by its Notified Body, the BSI Group, the Netherlands B.V. for its implants and abutments.
This signifies that Neoss Group's Quality Management System and its implants and abutments meet the requirements of the new MDR implemented by the European Union.
The new EU Medical Devices Regulation 2017/745 (MDR) replaces the former European Medical Device Directive 93/42/EEC (MDD), and brings EU legislation into line with technical advances, changes in medical science and progress in law-making.
The new MDR regulation contains a series of important improvements including establishing a comprehensive and accessible EU database on medical devices with a device traceability system based on a unique device identification.

Neoss® Group receives EU Medical Device Regulation (MDR) certifications for implants and abutments

Retrieved on:

Thursday, October 12, 2023

ZÜRICH, Oct. 12, 2023 /PRNewswire/ -- Neoss Group, a leading innovator in dental implant solutions, is proud to announce that it has received EU Medical Device Regulation (MDR) certification by its Notified Body, the BSI Group, the Netherlands B.V. for its implants and abutments.

Key Points:

ZÜRICH, Oct. 12, 2023 /PRNewswire/ -- Neoss Group, a leading innovator in dental implant solutions, is proud to announce that it has received EU Medical Device Regulation (MDR) certification by its Notified Body, the BSI Group, the Netherlands B.V. for its implants and abutments.
This signifies that Neoss Group's Quality Management System and its implants and abutments meet the requirements of the new MDR implemented by the European Union.
The new EU Medical Devices Regulation 2017/745 (MDR) replaces the former European Medical Device Directive 93/42/EEC (MDD), and brings EU legislation into line with technical advances, changes in medical science and progress in law-making.
The new MDR regulation contains a series of important improvements including establishing a comprehensive and accessible EU database on medical devices with a device traceability system based on a unique device identification.