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Welcome to the BSI Blog.

Read all that our experts have to say in our latest blogs below or navigate straight to your chosen topic using the topics pannel.

Welcome to the BSI Blog.

Read all that our experts have to say in our latest blogs below or navigate straight to your chosen topic using the topics pannel.

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2020

New guidance on regulatory pathways for personalized medical devices

The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world. They have recently issued a final guidance document - Personalized Medical Devices – Regulatory Pathways.

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Machine learning and medical devices: data quality and bias

Data quality is a key factor in the success or failure of a machine learning system; in fact, data quality is as or more important than the machine learning algorithm.

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Updated guidance on packaging for terminally-sterilized devices

Guidance on the application of the BS EN ISO 11607 series of standards, which specifies requirements for sterile barrier systems, is being balloted.

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Microbiological methods and sterilization

There are several microbiological methods that are used in developing, validating and routinely controlling sterilization processes.

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Do you have sufficient clinical evidence for your medical device?

The Medical Device Coordination Group (MDCG), which is composed of representatives of Member States and chaired by the EU Commission, has issued four further guidance documents on clinical investigation and evaluation.

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Connected Learning Live brings the classroom to you

As new risks have emerged, many organizations have had to adapt the way in which they function. With many industries beginning to operate again, what can employers do to support their staff’s development and better prepare them for when they return to work?

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Restoring confidence in the travelling public

Restoring confidence in the travelling public will be key to regenerating the aerospace sector following COVID-19. Find out more about the challenges faced by airports and airlines in the ‘next normal’ and considerations for the sector to consider during the rebuild and recovery phase.

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Trust and machine learning AI in medical devices

If medical device regulators, clinicians, and patients are going to reap the benefits of machine learning AI, it is critical that an appropriate level of trust in these systems be established by a collaborative regulatory system.

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Reopening and rebuilding the automotive sector following COVID-19

What is the next normal for automotive? Find out more about the new automotive landscape and what organizations operating in this sector should consider as they drive their return to work plans forward.

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PMCF plans and the MDR date of application

PMS requirements under the MDR must be met from 26 May 2021; however, some companies have questioned whether this also applies to the development of PMCF plans.

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Are your Class I devices ready for the MDR?

Even with the postponement of the date of application for the MDR to 26 May 2021, manufacturers still need to pay attention to devices for which there are no transitional provisions.

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Meeting net zero, with help from hydrogen

How important is hydrogen to achieving net zero targets? Countries around the world, including the UK, are trying pioneering new ways to use hydrogen to meet their emissions targets. We explore how hydrogen is being used as a fuel for the future.

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Delay to implementation of the Medical Devices Regulation

Postponement of the date of application of the MDR provides some respite to all those manufacturers, notified bodies and competent authorities trying to deal with the demands of the COVID-19 pandemic.

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Validation and routine control of sterilization processes

Standards for validation and routine control have a common format and use a common set of definitions.

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Machine-learning AI—What makes it different?

Machine learning AI systems, unlike simple rules-based systems, are cognitive in some sense and can modify their outputs accordingly.

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Updates to the list of standards harmonized for the European medical devices Directives

On 25 March 2020, three Commission Implementing Decisions on harmonized standards were issued to support the MDD, AIMDD and IVDD. This is a new format for updating the list of harmonized standards.

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New standard on information to be supplied by the manufacturer of medical devices

ISO 20417 sets out requirements for the identification, marking and labels on a medical device or accessory, and the information necessary to accompany the device or accessory.

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Progress on European and international standards on symbols for medical device labelling

Ballots on amendment to European adoption and new international edition of ISO 15223-1.

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Designating of medical devices as sterile and the MDR

The MDR presents requirements for sterile devices but does not provide a definition of the term ‘sterile’. The EN 556 series of standards defines requirements for designating devices as sterile.

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Sterilization, harmonization and the state of the art

Work is in progress to include Annex Zs into new editions or amendments to the applicable sterilization and aseptic processing standards.

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Notified Body capacity for In Vitro Diagnostics

Arguably the biggest change in the IVDR is the introduction of a risk-based approach to classification in combination with increased Notified Body oversight.

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Risk classification and the IVDR: an introduction

The new system of risk classification of IVD medical devices is one of the few radical changes brought about by the new medical device regulations. It aligns the classification of IVD medical devices with other medical devices and international practice as advocated by the GHTF.

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Managing healthcare cybersecurity in 2020 pt.2

It’s widely accepted that healthcare has lagged behind other industries when it comes to cybersecurity, and that the industry needs to close the gap. Thankfully, healthcare managers can use standards to build resilience across diverse cybersecurity fronts simultaneously.

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Managing healthcare cybersecurity in 2020 pt.1

With significant data breaches hitting the headlines each year, healthcare cybersecurity is a major and expanding area for investment. Some experts predict the market will grow by almost 20% over the next five years, and it’s not difficult to see why.

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Where is the consumer genetic testing industry headed?

From uncovering health risks to long lost family, consumer popularity for DNA testing has soared. This has put a spotlight on the quality and purpose of these test kits. We explore the challenges and opportunities within the consumer genetic testing market.

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Relationship between the revised risk management standard and European regulatory requirements

The final draft of EN ISO 14971 circulated for ballot included drafts for five European Annexes Z. However, these Annexes Z were not included in the published text. This was because comments received from the independent review of the Annex Zs were taking time to resolve.

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Three tips for implementing the MDR

BSI’s Bill Enos (Americas Senior Commercial Director, Medical Devices) and John Bis (VP of Medical Device Solutions Sales) offer three key pieces of advice for medical device companies trying to compete in the new EU MDR environment.

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Harmonized standards and the countdown to the MDR

Standards writers for medical devices, in particular anaesthetic and respiratory devices, are concerned about the EU Commission’s timelines for harmonized standards.

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Which smart cities are leading the electric transport revolution?

Driven by the impact on climate change and public health, the electric transport revolution is here. We explore the innovations from global smart cities that are transforming the way people live, work and travel every day.

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Risk control in the third edition of ISO 14971

Medical device manufacturers have several risk control options for eliminating or reducing risks to an acceptable level.

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Risk management plans and the new ISO 14971

The risk management process described in the new ISO 14971 consists of several steps. The first of these steps is the risk management plan. All risk management activities must be planned. The plan provides a roadmap for the risk management activities to be conducted during the life cycle of the medical device.

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Implementation and interpretation of IVDR classification rules

Under the IVDR the manufacturer is responsible for identifying the risk class applicable to its IVD device.

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The future of aerospace through the lens of sustainability: part 1

With uncertainty affecting many sectors, now is a good moment to take stock and understand what the future may hold, what will remain the same and what may be different in our futures for Aerospace.

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Helping the oil and gas sector to become more efficient

At this difficult time, how can oil and gas sector organizations improve productivity and reduce risk? One tried and tested route is by implementing a quality management system. To that end, in May we published BS EN ISO 29001:2020 Petroleum, petrochemical and natural gas industries — Sector-specific quality management systems — Requirements for product and service supply organizations.

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Revisions have updated the European standard for alloyed aluminium ingots

BS EN 1676: 2020 specifies the classifications and designations that apply to these grades, the conditions in which they are produced, their properties and the marks by which they are identified. This standard was first published in 1997 and then revised in 2010. The 2020 standard is its second revision.

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What Exploration & Production companies will get from the new ISO quality standard for the oil and gas sector

BS EN ISO 29001:2020 Petroleum, petrochemical and natural gas industries — Sector-specific quality management systems — Requirements for product and service supply organizations. This is a quality management standard for the oil and gas industry, but what can it do for E&P companies?

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We’ve made big changes to the important European standard for aluminium casting

BS EN 1706:2020 Aluminium and aluminium alloys — Castings — Chemical composition and mechanical properties specifies the chemical composition limits for aluminium casting alloys and the mechanical properties of separately cast test pieces for these alloys. It includes an annex on the selection of alloys for a specific use or process. This standard was first published in 1998 and then revised in 2010. The 2020 standard is its second revision.

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What you need to know about our new British Standard on water safety planning for buildings

Building water systems can be dangerous if they’re poorly designed and managed – yet it’s a problem that’s easily solved by a proper Water Safety Plan. We’ve just produced a new standard giving guidance on water safety planning. This blog post sets out why it’s been written and what it does.

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What mid and downstream organizations will gain from the new ISO quality standard for the oil and gas sector

In May we published ISO’s revised sector-specific quality management standard for the oil and gas industry. This blog post looks at what this standard can do to help post-production companies in the sector.

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We’ve made big changes to the important European standard for aluminium casting