SMART news, SMART quality & compliance
Medical Devices under the EU´s Changing Regulatory Framework
Some of the earliest known medical devices were being used in dental procedures between 7,500-9000 years ago in a Neolithic farming community from the Mehrgarh site (Indus Valley) in what is today, western Pakistan. Excavations of the site’s graveyard point to a 1,500-year-old farming community employing a long tradition of early dental techniques, as specifically observed in the molars of 9 adults from the area.[i] Flint-tipped bow drills used in early enamel drilling techniques consisted of assemblages of bone, shell, calcite, turquoise, lapis[ii], and other stones. Medical devices are products or equipment intended generally for medical use. [iii] Whilst there…
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SMART quality & compliance
What are the principal differences between the conformity assessment process of a medical device in the USA and in the European Union?
Figure 1: Comparison of European and US Conformity Assessment process of Medical Devices. Adapted from European law and United States law. Copyright 2020, Kvalito Consulting Group. The difference in the conformity assessment process between the European Union and the USA, is the need of a notified body in the European Union. The notified body is an organization designed by a member state to assess the conformity of products against the current European regulations and directives. The legal manufacturer of the medical device must contact a Notified Body (not necessarily from his own country) in order to obtain the CE mark…
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SMART quality & compliance
Special circumstances require special measures FDA announced temporary changes related to onsite audits requirements
In response to the global pandemic of COVID-19, the FDA temporarily does not enforce supplier verification onsite audit requirement for receiving facilities and importers, if other supplier verification methods are used instead. This applies for an onsite audit in the following circumstances: Onsite verification activity audit for an approved supplier conducting by a receiving facility or Foreign Supplier Verification Program (FSVP), as reflected by its written food safety plan or FSVP. Onsite audit for a supplier in a region or country covered by a government travel restriction or travel advisory related to COVID-19; (e.g France, Italy, Spain…) Onsite audit of…
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SMART quality & compliance
Bite-sized Knowledge: Medical Device Regulation
2A Regulation shall be applied in its integrality in all the European Union. Unless a Directive is an objective provided by the European Union, each country is free to develop its own measures to achieve this objective. Figure 1: Overview of the difference between Direction and Regulation. Adapted from European Law. Copyright 2020, Kvalito Consulting Group. Citizens and Companies implement their policy (act) according to their National law which is an interpretation of the European law. Citizens and companies implement their policy (act) according to European law. What are the changes in Medical Devices regulation? The European Parliament has…
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SMART quality & compliance
Health Technology Software Quality & Compliance
“Once a new technology rolls over you, if you’re not part of the steamroller, you’re part of the road.” Stewart Brand Health Technology is defined by the World Health Organization (WHO) as “the application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of lives”. However, as IT professionals in the life sciences, we focus on the Health Technologies that use software to perform their intended use. In recent years, we have witnessed how health and technology have increasingly come together. Whilst in the old…
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SMART quality & compliance
LabWare Vs LabVantage: What LIMS can best fit your customer needs?
LabWare Vs LabVantage: What LIMS can best fit your customer needs? “The important thing is not your process. The important thing is your process for improving your process.” Clara Sayrol A Laboratory Information Management System (LIMS) is a software that allows you to effectively manage laboratory operations and its associated data. By using a LIMS, your laboratory can automate workflows, integrate instruments, and manage sample analysis results as well as tracking associated information. Most companies whose laboratories perform pharma analysis or evaluation of human samples as part of clinical trials require systems that comply with relevant European Union Directives (e.g….
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SMART quality & compliance
New Medical Device Regulations (MDR) demand Quality Management Systems (QMS) for Software as a Medical Device (SaMD)
“Innovation is the calling card of the future.” Anna Eshoo It is remarkable, alone in the iOS App Stores, there are tens of thousands of apps which are registered as Software as a Medical Device (SaMD). With the new Medical Device Regulations (MDR) becoming effective in 2020, the companies that have developed these apps will need to perform considerable upfront review and update activities because of changes to classification, and as a consequence of this, most will need to set up a Quality Management System (QMS) to support the lifecycle of their products. The major challenge for these innovative, often…
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SMART quality & compliance
GDPR- Changes in Data Privacy Protection Affects Multinational Businesses
This week, effective May 25th, 2018 the General Data Protection Regulation (GDPR) will be valid in the European Union (EU). This regulation harmonizes data privacy laws across Europe and replaces the current data protection directive 95/46 EC. The GDPR is a complex piece of legislation comprising 11 chapters, 99 articles and 173 recitals. The aim of the GDPR is the protection of the data privacy of each individual (data subject). In short, the protection against abusive data processing, the protection of the right to informational self-determination, the protection of personal rights in data processing, as well as privacy protection must be ensured to be compliant with GDPR. The following article…
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SMART quality & compliance
Data Integrity- where GxP, IT-Security and Data Privacy come together
Data Integrity (DI), a vital part in the Compliance Framework of Life Science Companies, is mostly associated with GxP, but, it also applies to Information/IT-Security and Data Privacy. Take patient data of clinical studies, for example. Data Integrity in general Data Integrity is the maintenance and assurance of the accuracy and consistency of data over its entire life-cycle, and is a critical aspect to the design, implementation and usage of any system which stores, processes, or retrieves data. Data Integrity in the GxP-Environment Data Integrity presents a major challenge to biotechnology and pharmaceutical companies as information needs to…
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SMART quality & compliance
Data Integrity: Risks and Solutions
To ensure patient health and product quality, adhering strictly to Good Manufacturing Practice (GMP) is essential. One part of GMP, which is increasing in importance within the last few years due to higher FDA focus, is Data Integrity. Data Integrity means the overall documentation of every GxP-relevant activity performed during the whole product life cycle. The FDA recommends that this documentation should be based on the ALCOA principles. To guarantee Attributable, Legible, Contemporaneous, Original and Accurate documentation, life-science companies increasingly seek experts for advice. Focusing on data integrity by kicking off respective projects and hiring consulting experts within this field…
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