The EU’s In Vitro Diagnostics (IVD) Regulation: a summary of the regulatory requirements for December 2017

Source URL: www.genewatch.org

WELCOME ABOUT US • CE-MARKING • INTERNATIONAL REGISTRATION • QUALITY AND RISK MANAGEMENT • FULL SERVICE • EXPERTISE • CONTACT MEDICAL DEVICES & IN VITRO DIAGNOSTICS REGULATORY

Source URL: regenold.com

Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases - Draft Guidance for Stakeholders and Food and Drug Administration

Source URL: www.fda.gov

• Food and Drug Administration
• Health
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• Pharmaceuticals policy
• Personal life
• Pharmaceutical industry
• Healthcare quality
• Federal Food
• Drug
• and Cosmetic Act
• Medical device
• Validation
• Center for Devices and Radiological Health
• RNA-Seq

2015 Business Review ABBOTT 2015 ANNUAL REPORT DIAGNOSTICS TIMELY INFORMATION

Source URL: prod3.dam.abbott.com

• Medicine
• Business
• Health care
• Abbott Laboratories
• Lake Bluff
• Illinois
• Medical tests
• Alere
• Point-of-care testing
• In vitro
• Blood type

Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics - Draft Guidance for Stakeholders and Food and Drug Administration Staff

Source URL: www.fda.gov

• Biological databases
• Genomics
• Biology
• Bioinformatics
• Molecular biology
• Pharmacology
• GeneTalk

1st Meeting on Controversies in preconception, preimplantation and prenatal genetic diagnosis: How will genetics technology drive the future?

Source URL: www.comtecmed.com

• Medical genetics
• Natera
• Preimplantation genetic diagnosis
• Sequenom
• Genetic counseling
• Prenatal diagnosis
• Genetic testing
• Molecular diagnostics
• In vitro fertilisation
• DNA paternity testing
• Draft:Ariosa Diagnostics
• Predictive medicine

Abbott Diagnostics Overview Abbott is a global leader in in vitro diagnostics and offers a broad range of medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, molecul

Source URL: prod3.dam.abbott.com

• Medicine
• Health
• Business
• Medical diagnosis
• Medical tests
• Abbott Laboratories
• Lake Bluff
• Illinois
• Companion diagnostic
• Qiagen
• Medical laboratory

aroundtheindustry In Vitro Diagnostics Can E6E7 Alter The Competitive Balance In The Crowded HPV Test Market?

Source URL: www.oncohealthcorp.com

IN VITRO AND COMPANION DIAGNOSTICS Solutions for the complexities of IVD and CDX development Comprehensive regulatory, clinical, and quality services Experienced team of regulatory, clinical, and quality experts to suppo

Source URL: www.precisionformedicine.com

Key Messages on the Commission Proposal for a Regulation on In Vitro Diagnostic Medical Devices Focus Companion Diagnostics High-Level Messages: EBE-EFPIA welcome the Commission Proposal as an important step to ensure a

Source URL: www.ebe-biopharma.eu