MDSAP

Global Drug Delivery Devices Market Report 2022: Featuring Key Players F. Hoffmann-La Roche, 3M Company, Pfizer & Baxter International - ResearchAndMarkets.com

Retrieved on: 
Wednesday, July 20, 2022
Pharmaceutical, Health, Medical Devices, WHO, Midsayap Diagnostic Center and Hospital, Diabetes, Asia-Pacific, MDSAP, World Health Organization, Conditional sentence, Moyamoya disease, Cancer, Hospital, IHD, Drug delivery, Ophthalmic drug administration, Degenerative disease, Route of administration, Stroke, Death, Lists of countries and territories, Health care, Growth, Administration, Prevalence, Medical device, Pharmaceutical industry

The "Global Drug Delivery Devices Market Report 2022" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Drug Delivery Devices Market Report 2022" report has been added to ResearchAndMarkets.com's offering.
  • Asia Pacific was the second-largest region in the drug delivery devices market.
  • The regulatory changes related to medical devices is expected to restraint the growth of drug delivery devices market.
  • 1) By Route Of Administration: Oral Drug Delivery; Injectable Drug Delivery; Topical Drug Delivery; Ocular Drug Delivery; Pulmonary Drug Delivery; Nasal Drug Delivery; Transmucosal Drug Delivery; Implantable Drug Delivery
    2) By Patient Care Setting: Hospitals; Diagnostic Centers; Ambulatory Surgery Centers/Clinics; Home Care Settings; Other Patient Care Settings

Establishment Labs Releases 2021 Sustainability Review

Retrieved on: 
Tuesday, July 19, 2022
Environment, Surgery, Medical Devices, Women, Professional Services, Sustainability, Health, Consumer, Environmental, Social and Governance (ESG), Research, Global, CEO, IDE, Woman, Security (finance), Risk, GRI, U.S. Securities and Exchange Commission, Form 10-K, Freedom, Time, Revlon, Inc. v. MacAndrews & Forbes Holdings, Inc., Annual report, Private Securities Litigation Reform Act, Securities Exchange Act of 1934, Carbon, 21 CFR 820, Health, Adoption, Breast cancer, Health and Safety Executive, United Nations, Environment, Sustainable Development Goals, Goal, Exercise, Securities Act of 1933, List of Nature Research journals, NASDAQ, Harwell Science and Innovation Campus, Industry, COVID-19, Motiva, MDSAP, ESTA, FDA, Clinical trial, Sustainable Development Goals and Lebanon, Awareness, Medical device, Risk management, Pharmaceutical industry

Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, today announced publication of its 2021 Sustainability Review to coincide with the fourth anniversary of the companys public listing on NASDAQ.

Key Points: 
  • Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving womens health and wellness, principally in breast aesthetics and reconstruction, today announced publication of its 2021 Sustainability Review to coincide with the fourth anniversary of the companys public listing on NASDAQ.
  • We are presenting our 2021 Sustainability Review as an exercise in transparency, so that all of our stakeholders can review our progress with this vision and our efforts in support of environmental and social issues in our communities.
  • Among the topics included in the 2021 Sustainability Review are:
    References to the Global Reporting Initiative (GRI) Standards for Energy Consumption, Emissions, and Health and Safety topics as well as the Sustainable Development Goals (SDGs) outlined in the United Nations resolution The 2030 Agenda.
  • Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving womens health and wellness.

Richardson Healthcare Receives MDSAP Certification and Expands CT Tube Business into Canada

Retrieved on: 
Monday, July 11, 2022
System, Aviation, Certification, Solution, MDSAP, U.S. Securities and Exchange Commission, Calibration, Health, Program, Electronics, Donaueschingen, Company, Nasdaq, Medical device, Maintenance, Health care, RF, Sale, GLOBE, CT, Hospital, Efficiency, Google Images, Security (finance), NASDAQ

LAFOX, Ill., July 11, 2022 (GLOBE NEWSWIRE) -- Richardson Healthcare , a Division of Richardson Electronics, Ltd. (NASDAQ: RELL), announces the company received its MDSAP certification and Canadian Device License allowing its flagship ALTA750 CT Tube to be sold in Canada.

Key Points: 
  • LAFOX, Ill., July 11, 2022 (GLOBE NEWSWIRE) -- Richardson Healthcare , a Division of Richardson Electronics, Ltd. (NASDAQ: RELL), announces the company received its MDSAP certification and Canadian Device License allowing its flagship ALTA750 CT Tube to be sold in Canada.
  • Achieving the MDSAP certification and expanding into Canada reaffirms our commitment to the healthcare industry and producing the highest quality products," said Edward J. Richardson, Chairman, Chief Executive Officer, and President.
  • As part of the MDSAP certification process, Richardson participated in a thorough audit of its quality system processes and product quality requirements.
  • With this certification and the Canadian Device License , our Canadian customers can be confident that Richardson Healthcare is dedicated to maintaining the highest level of quality, efficiency, and responsiveness required by their healthcare community.

GT Medical Technologies Earns ISO and MDSAP Certifications

Retrieved on: 
Wednesday, June 29, 2022
FDA, Patient, LinkedIn, 3D, GMED, Brain, Malignant meningioma, Compliance, Cancer, International Organization (journal), MDSAP, Certification, ISO, Radiation, Standard of care, Medical device, Medtech, Safety, Twitter, Medical imaging

TEMPE, Ariz., June 29, 2022 /PRNewswire/ -- GT Medical Technologies announced today that it has earned the International Organization for Standardization (ISO) 13485:2016 certification from GMED.

Key Points: 
  • TEMPE, Ariz., June 29, 2022 /PRNewswire/ -- GT Medical Technologies announced today that it has earned the International Organization for Standardization (ISO) 13485:2016 certification from GMED.
  • The certification demonstrates the company's compliance with medical device quality management system requirements under the Medical Device Single Audit Program (MDSAP).
  • GT MedTech earns ISO/MDSAP certifications, a key achievement in the global expansion plans for FDA-cleared GammaTile.
  • ISO/MDSAP certifications emphasize a key achievement in the global commercial expansion plans for GT Medical Technologies' FDA-cleared GammaTile Therapy.

Internal Auditing to MDSAP Course: Concepts and Practices in Aligning the Internal Audit Program Webinar - ResearchAndMarkets.com

Retrieved on: 
Wednesday, June 22, 2022
Other Professional Services, Professional Services, Health, Medical Devices, MDSAP, FDA, BR, Company, JP, Regulatory affairs, Program, Internal, Single use medical device reprocessing, Internal audit, Audit, Medical device

The "Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program" webinar has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program" webinar has been added to ResearchAndMarkets.com's offering.
  • This webinar will give you a clear structured overview and introduction, how to apply MDSAP-Requirements in your internal audit program and to conduct internal audits with MDSAP requirements.
  • First you learn to identify the relevant requirements, second you learn how to implement the identified requirements into your audit program.
  • How to setup and audit program under MDSAP?

Quality and Regulatory Compliance Expert Joins NDA Partners

Retrieved on: 
Wednesday, June 8, 2022
Regulation, Lead, Chemistry, Clinical quality management system, CFR, Good manufacturing practice, Program, Research, Biotechnology, MBA, Pharmacokinetics, USP, Partner, GMP, University, University of Winnipeg, ISO, MDSAP, Compliance, Toxicology, Quality management system, NDA, CMC, GDP, Pharmaceutical industry, Medical device, EU

WASHINGTON, June 8, 2022 /PRNewswire-PRWeb/ -- NDA Partners General Manager, Eric Fish, announced today that Becki Hiebert, a quality and regulatory compliance professional, has joined the company as an Expert Consultant. Ms. Hiebert has more than 10 years of experience supporting medical device and pharmaceutical companies with GMP, GDP, and regulatory compliance. She has experience developing, implementing, and maintaining quality management systems, ISO 13485, 21 CFR 820, MDSAP, and EU MDD/MDR standards, conducting audits to ensure compliance, and providing training and support on quality systems.

Key Points: 
  • NDA Partners General Manager, Eric Fish, announced today that Becki Hiebert, a quality and regulatory compliance professional, has joined the company as an Expert Consultant.
  • WASHINGTON, June 8, 2022 /PRNewswire-PRWeb/ -- NDA Partners General Manager, Eric Fish, announced today that Becki Hiebert , a quality and regulatory compliance professional, has joined the company as an Expert Consultant.
  • She also served as Regulatory and Quality Manager with Nanostics and in quality assurance and research roles with Gilead Alberta.
  • According to Ms. Roberta (Bobbi) Druyor-Sanchez , Manager of NDA Partners' Quality Management Systems and Quality Systems Regulation practice, "Ms. Hiebert's quality and regulatory compliance experience will be valuable to medical device companies developing quality management systems to be compliant with ISO standards and EU MDD/MDR requirements.

TÜV SÜD Receives Accreditation for MRI Safety Testing as Part of its Expansion Plan

Retrieved on: 
Wednesday, June 8, 2022
FDA, Medical Devices, Health, Other Technology, Technology, Maritime Industrial Services, National Voluntary Laboratory Accreditation Program, ISO 9001, EMC, Article 102 of the Treaty on the Functioning of the European Union, Pressure, CEO, Torque, Product-service system, Environment, ISO/IEC, Accreditation, Association of American Medical Colleges, Solution, NRTL, Economic union, Heat, American Association, FDA, FORCE America, Inc., SCC, Electromagnetic compatibility, ISO, European Economic Community, MDSAP, Health care, ISO 14001, Association, Certification, Efficiency, Magnetic resonance imaging, AS9100, MRI, ISO 13485, Safety, Lead, Medical device, Medical imaging

MRI Safety Testing is crucial for medical devices used within a magnetic resonance imaging (MRI) environment.

Key Points: 
  • MRI Safety Testing is crucial for medical devices used within a magnetic resonance imaging (MRI) environment.
  • The MRI Safety Testing laboratory is an extension to more than 55,000 square feet of facilities in New Brighton, MN, offering end-to-end testing solutions for all medical devices.
  • Krishna Singhal, Ph.D., and Technical Lead for TV SD's MRI Safety group explains, "We have established a state-of-the-art laboratory to perform MRI Safety testing for medical devices at both 1.5T and 3T.
  • TV SD also offers a range of device testing services, including electromagnetic compatibility (EMC) and biocompatibility testing solutions.

ClearPoint Neuro Announces Receipt of MDSAP Certification

Retrieved on: 
Thursday, June 2, 2022
Medical device, Company, Program, Research, Food, Device, Quality, Security (finance), U.S. Securities and Exchange Commission, Biopsy, Nasdaq, Solution, Therapy, Brain, FDA, Growth, GLOBE, Health Canada, Patient, FDA Center for Devices and Radiological Health, Medication, MDSAP, COVID-19, Compliance, Quality of life, Lists of diseases, Industry, Certification, Medicines and Healthcare products Regulatory Agency, CNS, Particular, Paper, Health

SOLANA BEACH, Calif., June 02, 2022 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the Company), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced the receipt of certification for the Medical Device Single Audit Program (MDSAP).

Key Points: 
  • SOLANA BEACH, Calif., June 02, 2022 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the Company), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced the receipt of certification for the Medical Device Single Audit Program (MDSAP).
  • The fourth pillar of ClearPoints growth strategy is global expansion for which MDSAP certification is essential.
  • This certification validates our ongoing commitment to maintaining the highest quality assurance standards within the medical device industry as required by regulatory authorities across the world, said Megan Faulkenberry, Vice President of Quality and Regulatory at ClearPoint Neuro.
  • The ClearPoint Neuro Navigation System has FDA clearance, is CE-marked, and is installed in over 60 active sites in the United States, Canada, and Europe.

Establishment Labs to Present at the Jefferies Healthcare Conference

Retrieved on: 
Monday, June 6, 2022
Health, Medical Devices, Consumer, Women, Surgery, General Health, Biotechnology, Diversified Specialty Institute Holdings, Inc., IDE, Conference, Motiva, Webcast, 21 CFR 820, FDA, MDSAP, ESTA, NASDAQ, Clinical trial, Pharmaceutical industry

A live webcast of the presentation will be available on the Establishment Labs investor relations website at https://investors.establishmentlabs.com/ .

Key Points: 
  • A live webcast of the presentation will be available on the Establishment Labs investor relations website at https://investors.establishmentlabs.com/ .
  • An archived version of the webcast will be available on the same website following completion of the event.
  • Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving womens health and wellness.
  • In 2018, Establishment Labs received an investigational device exemption (IDE) from the FDA for the Motiva Implant and began a clinical trial to support regulatory approval in the United States.

Nonacus Welcomes Natalie Wide as Director of Quality Assurance & Regulatory Affairs

Retrieved on: 
Tuesday, May 24, 2022
Quality, DNA, NGS, Certification, Regulatory affairs, Patient, Genetic testing, Solution, IVD, Workflow, MHRA, BSI, Translation, Research, Cancer, Industry, IVDR, Liquid biopsy, MDR, PCR, MDSAP, Lists of diseases, Precision medicine, Diagnosis, ISO, Quality assurance, CEO, Medical device, Medical imaging, EU

BIRMINGHAM, England, May 24, 2022 /PRNewswire/-- NonacusLtd, leading provider of genetic testing products for precision medicine and liquid biopsy, is very pleased to announce the appointment of Natalie Wide as Director of Quality Assurance & Regulatory Affairs.

Key Points: 
  • BIRMINGHAM, England, May 24, 2022 /PRNewswire/-- NonacusLtd, leading provider of genetic testing products for precision medicine and liquid biopsy, is very pleased to announce the appointment of Natalie Wide as Director of Quality Assurance & Regulatory Affairs.
  • Commenting on this appointment, CEO of Nonacus, Chris Sale said, "we are really excited to have Natalie join our team.
  • ", stated Natalie Wide, Director of Quality Assurance & Regulatory Affairs, Nonacus.
  • For further media information please contact Paula Miquel, Head of Marketing, Nonacus Ltd, e-mail: [email protected] ,+44 7956 988416