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Posts
- 2013 MedTech retrospective
- 2013 to Be a Big Year for Biocompatibility; Nelson Labs Participates in Potential Updates
- 2016 Year in Review
- 2017 Fall AAMI Sterilization Standards Meetings Update
- 2017 Mid-year Thought Leadership Update
- 2017 Spring AAMI Sterilization Standards Meeting Update
- 2018 Educational Resources
- 3-D Medical Device Validation
- 3D Printed Devices and Biocompatibility
- 3D Printed Devices and Biocompatibility: Details of the Material Curing Process
- 3D Printed Devices and Biocompatibility: Material Aeration
- 3D Printed Devices and Biocompatibility: Post-Printing and Finishing
- 3D Printed Medical Devices and Biocompatibility Whitepaper
- A Brief Introduction to Medical Device Biocompatibility
- AAMI Sterilization Standards Meeting Update on Processing of Reusable Medical Devices
- AAMI Survey on the Use of and Experiences with Method VDmax
- Accelerate Your Time To Market With Nelson Labs Accelerated Aging Testing!
- Accelerated Aging Package Testing
- Advances in in-vitro testing from the Society of Toxicology Meeting
- Alpa Patel Celebrated for Contributions to New Test Soils Standard
- Alternatives To In Vivo Biocompatibility Testing
- ANSI/AAMI PB70: Closing the Gap
- Are Your Tissue Banking Processes Validated?
- ASTM Committee Meeting Updates for F02 and D10
- Become Compliant with MDR as Soon as Possible
- Benefits of Premarket and Postmarket Particulate Testing of Cardiovascular Devices
- Biocompatibility Advancements To Be Showcased At MD&M Minneapolis ǀ Nelson Laboratories
- Biological Indicator Resistance Testing
- BIOMEDevice San Jose Focus On Biocompatibility
- Celebrating Audrey Turley: 20 Years at Nelson Laboratories
- Challenging the Status Quo of Sterile Environments
- Chemical Passivation Test Ensures Passivated Medical Devices Don’t Corrode
- Cleanroom Renovation Complete
- Comments on “Reprocessing Guidance for Industry and FDA Staff,” issued March 17, 2015
- Complete EN 13795 Suite of Tests Offered by Nelson Laboratories
- Conduct Container Closure Integrity Testing Before Validation and Annually Thereafter
- Consider the Most Probable Number Method for Bioburden Testing
- Considerations for Sterilization and Biocompatibility of 3D-Printed Orthopedic Devices
- Considerations for Third-Party Reprocessing of Single-Use Medical Devices
- Container Closure Integrity Testing Through Mass Extraction
- Creative Proof
- Cytotoxicity Failure Program
- Determining a Valid Sample Size for Package Testing
- Does Your Non-patient Contacting Device or Surface Require a Cleaning and Disinfection Validation?
- Dr. Victoria Hitchins Remembered at Nelson Laboratories
- DuPont’s Tyvek Transition: Are You Prepared?
- EN14683 Harmonizes Bacterial Filtration Efficiency and Differential Pressure with ASTM F2100
- Endoscope Sampling Kit Now Available
- EO Residue Levels in Medical Devices: Best Practices for Demonstrating Compliance with ISO 10993-7
- EO Sterilization Validation: Overkill with Benefits
- Equipment Cleaning, Disinfection, and Sterilization Validations – The Tissue Industry’s Compliance Challenge!
- Establishing Bioburden Alert and Action Levels
- Estimated Economic Impacts of the Two Year Moratorium on the Medical Device Excise Tax
- Ethylene Oxide Batch Release—Use for Specialized Medical Devices or Those that Need to Go to Trials
- Europe Working to Update Facemask Standard to Align with United States
- Evaluating The Impact of Change with Chemical Characterization
- Expanded Particulates Testing and Water System Testing and Services in Itasca, IL
- Extractable/Leachable Chemistry Testing Strategies for Medical Devices
- FDA Guidance for ISO 10993-1: What to Expect
- FDA Proposes Ban on Powdered Surgeon’s Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon’s Gloves
- FDA Releases ISO 10993-1 Guidance Document
- FDA Safety Notice: Lubricious Coating Separation on Intravascular Devices
- Five Aspects of the ISO 11737-1:2018 Updates You Need to Know
- Flexible Endoscope Surveillance Testing Webinar Now Available
- FTIR in Assessment of Medical Devices
- Gram Stain Test Recommended for Genetic Testing
- Healthpack Conference 2018 Wrap Up
- How Chemical Characterization Can Supplement and Support Biocompatibility Testing
- How Clean is Clean Enough?
- How Clean is Your Cardiovascular Device?
- How the New FDA Biocompatibility Testing Guidance Could Affect You
- How to Select Sterile Barrier Systems for Reusable Medical Devices
- Human Factor Considerations for Medical Device Manufacturers
- Importance of Cleaning and Sterilization Validations, Even When they may Not be Required
- Important Considerations for Reusable Medical Endoscope Processing and Reprocessing
- Improving Medical Device Approval Timelines
- IMRP Roundup
- In Vitro Skin Irritation Breakthrough To Revolutionize Medical Device Testing
- In Vitro Skin Irritation Testing of Medical Devices
- Increase Efficiency by Combining Bioburden and Tests of Sterility
- Introduction to the Validation of Sterile Medical Devices: Sterilization, Packaging, Biocompatibility, Toxicology, and Reprocessing
- Is Your Biocompatibility Program on the Edge?
- Is Your New Device Clean? Learn More at BIOMEDevice Boston
- ISO 16775: The Medical Device Packaging Professional’s Latest “Must Have”
- ISO Committee Member Announced
- ISO Meeting and Biocompatibility Standards Update, Mishima, Japan
- ISO Meeting in Australia Updates International Standards for Medical Device Testing and Validation
- Jeffery Nelson Contributes on Panel for Biomed Professionals
- Justifying Family Groupings to Maximize Value for Cleaning and Sterilization
- LIVE Webinar: How to Develop a Risk-Based Safety Evaluation per New US FDA Guidance
- Manufacturers Should Test Tissue and Tissue Based Products for the Presence of Bacterial Endotoxins
- Marketing Hospital Textiles in the EU Market
- Martell Winters is Convener for ISO WG16
- Martell Winters Recognized at AATB
- Martell Winters Shares Expertise with University Students
- Material Characterization/Extractable Leachable Testing Services May Lower Cost and Time Commitment
- MD&M Texas
- Nelson Laboratories Celebrates 28 Years of Growth and Success
- Nelson Laboratories Exhibiting at MEDevice San Diego 2014
- Nelson Laboratories Launches New Tests
- Nelson Laboratories Now Performs Wet Bacterial Penetration Testing for EU
- Nelson Laboratories President/CEO Jeffery Nelson Talks MedTech With MDTmag.com
- Nelson Laboratories Science Council
- Nelson Laboratories Scientist Provides Clarification on Tissue Bank Cleaning Validations
- Nelson Laboratories Stays On Top of FDA Reusable Device Sterilization Guidelines and Changes
- Nelson Laboratories to Launch New Website
- Nelson Laboratories to Offer Free Biocompatibility Consultations During BIOMEDevice San Jose
- Nelson Laboratories To Provide Materials Selection, ISO 10993 and Reprocessing of Reusable Devices-Validation Updates at 2014 MD&M West
- Nelson Laboratories Utilizes Stromboli Oven Sample Changer with Karl Fischer Moisture Analysis
- Nelson Laboratories, Inc. Featured On Zions Bank Speaking On Business Radio Program
- Nelson Laboratories, Inc. Women in STEM Education (WISE) Committee
- Nelson Laboratories’ Experts Receive SOT Award
- Nelson Labs Adds New Quantitative Hemoglobin Assay to Improve Cleaning Validations
- Nelson Labs at Utah STEM Fest
- Nelson Labs Automates Bacterial Endotoxin Test
- Nelson Labs Contributes to STEM Education
- Nelson Labs Experts Invited to Present at Joint Conference
- Nelson Labs’ Scientists Awarded Best Published Paper 2017
- New FDA Guidance for 510(k) Submission of Orthopedic Medical Implants
- New FDA Guidance on Gowns Intended for Use in Health Care Settings
- New FDA OSEL Research Programs Webpages
- New US FDA Guidance on the Use of International Standard ISO 10993-1: Top 10 Changes
- Non-Porous Packaging Validation
- Open House to Celebrate Expanded and Upgraded Lab Facility in Itasca, IL
- Particulate Matter Testing Required for Injectable Solutions
- Passing the test: Why patient safety is paramount
- Physicochemical Testing Checks on Safety of Extracts
- Possible Replacement of the Rabbit Irritation Test with an In Vitro Model
- Programs funded to help interest students in Science, Technology, Engineering, and Math (STEM) in Utah schools
- Purple and Red: Gram Stain Test Contributes Important Information to the Sterilization Process
- Quick Guide to FDA’s Draft Guidance on 3D Printed Devices
- Regulatory Considerations and Revalidation Tests for Managing Change in Packaging Materials or Critical Supplies
- Regulatory Landscape for EO Residue Levels in Medical Devices
- Reprocessing Single-Use Devices
- Reusable Medical Devices: BI Selection, Overkill Validation Approaches, and First-Time Validation Pass Rates in Common Healthcare Steam Sterilization Cycles
- Single Use & Newly Manufactured Device Cleaning Validations
- Standardization of Test Soils for Reusable Medical Devices to Soon Become a Reality
- Sterilization Risk
- Successful Medical Device Cleaning Validations: What You Need to Know
- The New FDA Draft guidance for Biocompatibility: What You Need to Know
- The Risk-Based “Big Three”
- Three-Day Webinar Series: Medical Device and Pharmaceutical Testing Regulatory Updates, Trends, and Anticipated Changes
- Tissue Processing Equipment Validations: What You Need To Know
- TOC Testing Verifies Acceptable Levels of Organic Carbon
- Tolerable Contact Limits for Ethylene Oxide Residual Testing
- Top 3 Questions About Extractable/Leachable Testing
- Tribute to Dr. Scott Sutton; Review of Bioburden Contamination Control
- U.S. ISO Certified Experts Announced
- Understanding the Importance of TIR17 for Medical Device Manufacturers
- Understanding Validation for Verification Dose Maximum Sterilization
- Understanding Worst-case Conditions in ISO 18562 Testing
- Updated Pyrogenicity Considerations for New Medical Devices
- Updates from ISO 10993 Working Groups Italy Session
- USP Bioburden Control of Nonsterile Drug Substances and Products
- Visit Nelson Laboratories at OMTEC 2014
- Vitek or Genetic ID Testing: What They Are and How to Decide
- What are the Differences Between Respirators and Surgical Masks?
- What Medical Device Manufacturers Need to Know about FDA’s Predictive Toxicology Roadmap
- What You’ll Learn at the MD&M West Nelson Laboratories Classroom on Materials Selection and ISO 10993 Biocompatibility Update
- What You’ll Learn at the MD&M West Nelson Laboratories Classroom on Packaging Test Methods for Validation of Sterile Barrier Materials
- What You’ll Learn at the MD&M West Nelson Laboratories Classroom on Process Validations for Newly Manufactured Devices- Is Your New Device Clean?
- What You’ll Learn at the MD&M West Nelson Laboratories Classroom on Validation Considerations for Managing Human Factors in Reprocessing of Reusable Devices
- What You’ll Learn by Attending the MD&M West Nelson Laboratories Classroom on Ethylene Oxide Sterilization Validation Overview
- What You’ll Learn by Attending the MD&M West Nelson Laboratories Classroom on Radiation Sterilization Validation Overview
- When Do I Really Need to Perform an EO Requalification?
- Why Particulate Matter Testing Matters: Cardiovascular Medical Device Testing
- WISE Committee Showcases STEM Careers
Events
- BIOMEDevice San Jose 2018
- Categorizing Medical Devices Per ISO 10993-1
- Changing a colorant in an approved medical device, what should I know?
- Changing Expectations with Endoscope Reprocessing
- Chemical Characterization and Toxicological Risk Assessment for Medical Device Biocompatibility
- Cleaning Validations for Newly Manufactured Medical Devices and Single Use Implants
- Considerations for Third-Party Reprocessing of Single-Use Medical Devices
- Day 1: Assessing Biocompatibility for Medical Devices: Updates, Trends, and Anticipated Changes
- Day 1: Develop a Biological Evaluation Plan (BEP)
- Day 2: Understanding Test Options
- Day 3: Summarize all your findings in a Biological Evaluation Report (BER): The ISO 10993-1
- Developing a Biological Safety Evaluation
- Developing a Test Strategy and Plan
- Developing your Packaging Validation Plan
- Drug Delivery to the Lungs (DDL)
- Ethylene Oxide – Navigating Recent Standards Changes and Industry Challenges
- Ethylene Oxide Sterilization Validation
- Ethylene Oxide Sterilization- Batch Release Method
- Ethylene Oxide Sterilization, Revision of Annex E, Single Batch Release
- How to Address Regulatory Change in Your Current Biocompatibility Program
- IMRP 2019
- Learning From HAIs: Understanding Reprocessing Regulations, Validation & Human Factors
- New Approaches to Assessing Biocompatibility for Medical Devices
- New FDA Expectations for Endotoxin Testing
- New Guidance on Product Family Adoption for Radiation Sterilization: TIR 35:2016
- Packaging Design Validation Testing
- Packaging: Design for Sterilization
- Regulatory Requirements for Packaging Changes
- Satisfying ISO 18562 and FDA Biocompatibility Regulatory Requirements for Breathing Gas Pathways in Health Care Application
- The Validation of Sterile Medical Devices Amsterdam 2019
- The Validation of Sterile Medical Devices Philadelphia 2019
- The Validation of Sterile Medical Devices Salt Lake City 2019
- Understanding Ethylene Oxide Sterilization
- Updates & Trends from FDA; Including Recent ISO 10993 News
- What is Changing in the Global Regulatory Landscape
- When Do I Really Need to Perform an Ethylene Oxide Requalification?
Expert Bio
Testing
- Accelerated & Real-Time Aging
- Ames Mutagenicity Test
- Antibiotic Potency Test
- Antimicrobial Efficacy Studies
- Antimicrobial Preservative Effectiveness
- Bacterial & Viral Filtration Efficiency (BFE/VFE)
- Bacterial Endotoxins Test
- Biological Indicator – Population Verification
- Biological Indicator – Sterility Testing
- C13H24 and C21H40 Rubber Oligomers
- Cleaning Validation – Reuse Device
- Clinical Batch Release
- Compounds Screener Database
- Container Closure Integrity – Dye Immersion & Bacterial Immersion
- Container Closure Integrity – Mass Extraction
- Contract Sterilization – Sterigenics
- Cytotoxicity
- Cytotoxicity Failure Program
- D-Value Determination Studies
- Disinfection Efficacy Studies
- Disinfection Validation – Reuse Device
- E&L for Medical Devices
- Endoscopes and Scope Validations – Reuse Device
- Environmental Monitoring Supplies
- Environmental Monitoring Supplies – Air & Water
- Environmental Monitoring Tests – Air & Water
- EO Sterilant Residual Tests
- Ethylene Oxide Sterilization Validations
- Extractables & Leachables
- Filter Sterilization Validations
- Filtration Sterilization Validation
- Flammability Test
- Flexible Endoscope Sampling Kit
- Functionality & Repeated – Use Studies
- General Analytical Tests
- General Considerations
- General Physical Tests
- Genotoxicity
- Glove Testing
- Hemocompatibility
- Hydrostatic Pressure
- Implantation with Histopathology Tests
- Impurities Identification
- Impurities in Drug Components & API
- Inhalables OINDP
- Injectables & Parenterals
- Integrity & Strength Test
- Irritation
- Label Migration Studies
- Liquid Oral Dosage Forms
- Manufacturing Systems
- Material Characterization Screens for Raw Materials
- Method Development
- Microbial Cleanliness for Face Masks
- Microbial Enumeration for Nonsterile Products
- Microbial Identifications
- Mouse Lymphoma Testing
- Opthalmics
- Packaging Shelf Life Studies
- Particle Filtration Efficiency (PFE)
- Particulate Analysis
- Physicochemical USP Plastics Tests
- Product Bioburden – Medical Device
- Product Inoculations
- Product Sterility – Cleanroom
- Product Sterility – Isolator
- Radiation Quarterly Dose Audits (QDAs)
- Residual Manufacturing Materials
- Respirator Precertification Tests – NIOSH
- Sensitization
- Spray Impact
- Stability Studies – Pharmaceutical
- Standard Plate Counts
- Sterilization Bioburden Resistance
- Sterilization Exposure Cycles
- Sterilization Supplies (BIs & PCDs)
- Sterilization Validation – Reuse Device
- Sterilization Validations – Radiation
- Subacute & Subchronic Toxicity
- Surgical Face Masks and General-Use Masks – ASTM F2100 & EN 14683
- Surgical Gowns and Drapes – AAMI PB70 & EN 13795
- Synthetic Blood Penetration for Liquid Barriers
- Systemic Toxicity Test
- Tensile and Tear Resistance Tests for Fabrics
- Tissue Testing Services
- Topical Dosage Forms
- Toxicological Assessments
- Transportation and Distribution Performance
- Viral Penetration Test
- Water System Validations & Monitoring
- Whole Package Integrity
News
- Biocompatibility Advancements At MD&M Minneapolis
- Celebrate 30 Years Of Life-Saving Innovation With Nelson Laboratories At MD&M West!
- European Union Grants a Good Manufacturing Practice Certificate to Nelson Laboratories
- MD&M West 2015: Celebrating 30 Years at the Forefront of Medtech Innovation
- Medical Device Testing Thought Leader Encourages Exploration Of Careers In Science
- Nelson Laboratories and Healthmark have Joined Forces to Offer a Surveillance Tool for Testing of Duoendoscopes
- Nelson Laboratories Celebrates 30 Years Supporting Life-Saving Medical Device Innovation
- Nelson Laboratories Expands Service to Medical Device Manufacturers in Europe, Israel, and Turkey
- Nelson Laboratories Expands Testing Capabilities With Dedicated Analytical Chemistry Lab
- Nelson Laboratories Gains Certification from Australia’s Therapeutic Goods Administration (TGA)
- Nelson Laboratories Honored as a Leader in Science and Technology
- Nelson Laboratories Joins the Orthopedic Discussion By Way of Sterile Packaging Validation at OMTEC 2014
- Nelson Laboratories Launches Consulting Services for MedTech Companies
- Nelson Laboratories Launches Redesigned Website
- Nelson Laboratories To Provide Materials Selection, ISO 10993 and Reprocessing of Reusable Devices-Validation Updates at 2014 MD&M West
- Nelson Laboratories’ Scientist to Present Medical Device Sterilization Updates at MD&M East Conference
- Nelson Labs Announces Changes to Secure Customer Portal
- Nelson Labs Launches New Global Website to Improve Med Tech & Pharma Customer Experience
- Nelson Labs significantly expands lab operations and testing capabilities in Itasca, Illinois, to better serve customer needs
- Nelson Labs To Host Three Summer Career Open Houses
- Nelson Labs to Present Process Validations for Newly Manufactured Devices at BIOMEDevice Boston
- Nelson Labs Will Present on Medical Device Sterilization at MD&M Texas
- NRCM Certifies Five Nelson Laboratories’ Microbiologists
- NRCM Certifies Seven Nelson Laboratories’ Microbiologists
- Scientists at Nelson Laboratories Discover Extractable Positive Control for In Vitro Skin Irritation Testing of Medical Devices
- Sotera Health’s Nelson Labs announces acquisition of New Jersey-based Gibraltar Laboratories
- Sterigenics International and Noxilizer Announce Partnership
- Sterigenics International has Acquired Nelson Laboratories
- Sterigenics International LLC Acquires Toxikon’s European Laboratory Business
- Sterigenics International LLC Changes Name to Sotera Health LLC
