Dedicated to design & manufacturing for medical device
1-3 September 2021 | SWEECC H2&H4
Quality Control
2020.12.01 Ensuring Data Integrity and Security in Ultrasonic Welding for Medical Devices A look at how one equipment supplier upgraded its software to build in data integrity and security safeguards....... Read More
2020.11.10 What will pandemic disruptions mean for EU IVDR? Certification under the old EU In Vitro Diagnostic Directive (IVDD) cannot be grandfathered into IVDR. IVD manufacturers must start prioritizing product portfolios and conducting gap assessments now to ensure compliance by the May 2022 deadline....... Read More
2020.10.26 Why Should Medical Packagers Consider X-Ray Sterilization? Learn why X-ray irradiation is being considered as an alternative method to sterilize some polymer-based medical devices, such as wound care dressings, wearables, and ostomy appliances....... Read More
2020.09.10 7 Things to Consider When Using a Medical Device Contract Packager While economics often factor into the decision to enlist a contract packager, there are several other aspects medical device companies must consider.......... Read More
2020.08.24 Managing Testing Strategies Under the EU MDR Companies can improve their chances for a successful transition by leveraging their knowledge of their medical devices and understanding what each device’s categorization under the MDR means to its testing strategy....... 阅读更多
2020.08.21 Proposed Medical Devices Standard Will Help Validate Cleaning Methods An ASTM committee is developing a series of guides for validating cleaning instructions for medical devices....... 阅读更多
2020.08.20 4 Steps for Error-Free Coding on Pharmaceutical Packages Validation is a major component of pharmaceutical manufacturing, ranging from production systems, packaging equipment, and computer programs. The packaging printer is a critical element in the validation process...... 阅读更多
2020.08.12 Exceeding regulatory requirements: Beyond the checklist Many manufacturers run into issues as they adjust their devices and testing plans to meet updated regulatory requirements. Using a risk-based approach to predict and mitigate risks can help prevent costly setbacks. 阅读更多
Many manufacturers run into issues as they adjust their devices and testing plans to meet updated regulatory requirements. Using a risk-based approach to predict and mitigate risks can help prevent costly setbacks. 阅读更多
2020.06.15 Medical Device Extractables and Leachables Testing in 2020 Chemistry for toxicology (ChemTox) testing has evolved considerably in the last couple years. Here’s what you should consider for your own program. 阅读更多
Chemistry for toxicology (ChemTox) testing has evolved considerably in the last couple years. Here’s what you should consider for your own program. 阅读更多
2020.04.16 How to navigate testing for devices that use wireless technology The Federal Communications Commission (FCC) has a different testing requirements for wireless medical devices than the FDA. Here are some tips of choosing a testing method for FCC compliance. 阅读更多
The Federal Communications Commission (FCC) has a different testing requirements for wireless medical devices than the FDA. Here are some tips of choosing a testing method for FCC compliance. 阅读更多