Systematic Literature Review Tools - How To Choose One A variety of factors (e.g., the new EU MDR & IVDR requirements, finding and retaining top talent, and tight budgets, just to name a few) have influenced Medical Device and Diagnostic manufacturers to invest in technology that streamlines and automates required compliance activities. Systematic Literature
510k Submission Planning Before you start your 510k submission make sure you’re aware of the pitfalls. As a leading regulatory compliance company providing a suite of services to Medical Device Manufacturers, 510(k) submissions have been a hot topic of late! Being responsible for writing and submitting a 510(k) can seem overwhelming. Especially when
Post-Market Surveillance UK: Strengthening Medical Device Regulation in the UK The UK's medical device and in-vitro diagnostic device regulation is undergoing significant changes to enhance post-market surveillance (PMS) requirements. The MHRA (Medicines and Healthcare Products Regulatory Agency) conducted a consultation, which received responses supporting the need for more transparent and risk-proportionate PMS requirements.
Contact Lens Manufacturers: European Commission Amendments on UDI Requirements The European Commission has made significant amendments to Regulation (EU) 2017/745, which addresses medical devices, specifically focusing on the Unique Device Identification (UDI) system. This system plays a crucial role in ensuring the identification and traceability of medical devices in the market. Recent collaborations
Strategies for Successful CE Certification: Mitigating Non-Conformities and Streamlining Review Cycles Strategies to facilitate approval of CE certificate and limit review cycles from the notified Bodied for Legacy devices and new products are discussed below. Notified body reviewers commonly provide feedback related to claims, as the MDR does not use the specific term "clinical
Clinical Benefits & Equivalence: A Guide to EU MDR Clinical Evaluation There has been a lot of emphasis on how the clinical benefits of a medical device are addressed in the clinical evaluation. EU MDR defines the clinical benefit as “the positive impact of a device on the health of an individual, expressed in terms
Extending MDR/IVDR Transitional Period and Eliminating 'Sell-Off' Periods - (EU) 2023/607 The European Parliament and Council have put Regulation (EU) 2023/607 into effect on March 20, 2023. This new Regulation modifies Regulations (EU) 2017/745 and (EU) 2017/746, which pertain to the transitional period for medical devices and in vitro diagnostic medical devices. The Regulation eliminates
Europe PMC Integration in CAPTIS™ The EU Medical Devices Regulation (MDR) requires clinical evaluation reports (CERs) to provide valid and reliable evidence to demonstrate the safety and performance of a medical device before it can be placed on the EU market. Literature is an important source of evidence for these reports and provides a
Time Saving in Literature Reviews with CAPTIS Celegence’s medical writing teams have been utilizing and benefiting from CAPTIS™ since 2020 and have noticed that this software solution has single-handedly made literature reviews more efficient and enjoyable. With features like automatic metadata and full-text PDF retrieval, article tagging, ability to edit the search strategy at
Data Extraction Tables in CAPTIS™ Published scientific literature is an essential dataset reviewed as a part of the Clinical Evaluation for a medical device (Article 16 of the Medical Device Regulation (EU) 2017/745) or Performance Evaluation for an in-vitro diagnostic medical device (Annex XIII of In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746).
