Risk Management for Medical Devices – ISO 14971 2007

If your design and manufacturing resources are spending too much time on documentation and not enough time on actual risk management and mitigation, you as a manager need to be looking for ways to simplify the work at hand.


Risk management overarches projects associated with a particular product family, given that risks will both remain and change as new design features and medical indications for use evolve with a particular device.

During all phases of a project, any new consideration must be held up against the scrutiny of potential risk and harm to the health of people, damage to property, or to the environment during all stages of a product’s life cycle and supply chain.

Risk management is a process that involves many considerations, responsibilities, personnel, and the transfer of knowledge. Given that it transcends projects and even companies, it is particularly critical that key pieces of information survive these many hand-offs.

If you are constantly struggling to create, manage, and maintain all of the information found in the various Risk Management documents and files, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.

If your design and manufacturing resources are spending too much time on documentation and not enough time on actual risk management and mitigation, you as a manager need to be looking for ways to simplify the work at hand.

  • Risk management process as per ISO 14971
  • Management responsibilities
  • Qualification of personnel
  • Risk management plan
  • Risk management file
  • Bringing it all together –links to design and process


GMP Environmental Control for Pharmaceutical Clean Rooms

The subject of clean room contamination due to personnel is discussed.

Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.

Therefore, the design, validation and ongoing monitoring of a clean room HVAC system is necessary to assure the quality and safety of the pharmaceutical product. Also, a proper understanding and testing of the clean room environment according to international regulatory standards is important from a compliance perspective

It is important that a clean room’s HVAC system is fully understood, properly designed and properly validated. If this is accomplished, it will provide the environmental control necessary to meet the regulatory particulate and microorganism levels necessary to manufacture quality pharmaceutical product.

This webinar first details and explains the various US and international regulatory requirements for various clean room classifications. Next, the webinar provides a comprehensive overview of the mechanics of clean room HVAC. This includes engineering diagrams and schematics. HVAC equipment components are detailed as well as the automated control systems that are available. Clean room design considerations are included. Proper building construction and layout is necessary to achieve both optimum efficiency of the system and optimum cleaning and sanitization of the clean room.

The principles of HEPA filtration are described along with desired clean room airflow patterns and how to achieve them. Proper procedures for HEPA filter leak testing is included. The webinar then provides valuable information on differential pressure, air velocity , flow rates, and air pressure balancing. Temperature and relative humidity controls and specifications are also detailed.

Comprehensive procedures for cleaning and sanitization of the clean room environment are presented along with a review of the best disinfectants currently available along with their respective advantages and disadvantages. The subject of clean room contamination due to personnel is discussed. This includes both gowning technique and aseptic practices.

Finally, a full set of requirements for HVAC system validation is detailed. Ongoing monitoring of the clean room environment is discussed with respect to schedule, specifications and OOS (out-of-spec) actions that may be required.

  • Quality Assurance
  • Environmental Monitoring
  • Microbiology
  • Manufacturing
  • Validation
  • Engineering
  • Maintenance

Personnel Gowning and Aseptic Practices in Clean Room

Consumerization of Healthcare, AI, and the Shifting “Physician-Patient” Relationship

The next important step in enabling patients to inquire about their own personal health.

The classic story of disruptive technology is all too familiar. Travel websites replace agents by giving consumers access to the same rates. Uber offers transportation outside of the established taxi cab system. Amazon brings outlet shopping into our homes. The common thread in all these examples is the transfer of more power to consumers. These changes usually cut costs, increase efficiency and often force out those who cannot keep up. Most of these fundamental developments occur in fields that do not require highly technical expertise, such as housing and transportation, allowing consumers to take control without extensive training.

The specialized knowledge and professional barriers in medical practice have, for many years prevented consumer involvement — leaving control and decision making solely in the hands of the healthcare provider, with the patient largely on the receiving end of information that directly affects their care.

However, these barriers are beginning to crumble.

Over several decades, patients have become more active in pursuing better care and are looking for knowledge sources that can help them become more educated and active participants in their care. Recently, advancements in AI (artificial intelligence), big data analytics, mobile technology and cloud computing have started to enable patients to take greater control of their medical care, leading towards a major shift in the patient-physician relationship.

The first hint of the evolving physician-patient relationship started when medical information became accessible to the layperson. Websites such as WebMD began to make medical literature comprehensible, accessible and searchable. Beyond this, social media and patient blogs allowed people to compare their experiences with others’, creating a better understanding of what their symptoms may be telling them. However, this data was still too general and not personalized.

Patient access to their personal health records (via patient portals) was the next important step in enabling patients to inquire about their own personal health.

Next, mobile technology has allowed patients to track, store and manage their medical history with increasing accuracy. Furthermore, FDA-cleared wearables have advanced to provide vital signs and other sensor-related data, adding more dimensions to the personal clinical data stored on the consumer’s mobile.

Now, consumer-focused companies such as Apple, are providing consumers with access to their full medical records from multiple healthcare providers on their mobile devices. Together with the wearable sensor and patient-entered data, the patient now has access to a far more enriched, comprehensive and accurate up-to-date data than any of the individual healthcare providers treating him/her.

However, understanding the clinical implications of the data to the individual is challenging for most consumers. Consumers are flooded with their own clinical data, with limited ability to utilize this data to benefit their own health.

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The [Ultimate Guide] To Medical Device Inspection

I want to present the ultimate guide to medical device inspection, which I believe is going to live up to just what I am calling it: the ultimate guide to medical device inspection.

A medical device inspection. Ah! Is there a more dreaded exercise for a medical device manufacturer? If I were given a choice between taking up the world’s toughest rated examination and facing a medical device inspection, I would gladly opt for the former. A medical device inspection should rank right there ahead of the most difficult examination or task.

Alright. We knew this fact all along. So, why should I intimidate you by casting such aspersions on a medical device inspection? Fact is, a medical device inspection’s stringency is a little overrated. Am I not contradicting myself? On the surface, yes, but scratch a bit, and you will realize the truth of what I am saying.

Yes, medical device inspections are extremely difficult to the point of being scary. But the fundamental question is, for whom? A medical device inspection is a difficult one for only those who are unprepared for it. In other words, a medical device inspection is just like a highly rated competitive exam: it is tough if you are unprepared and manageable if you are prepared.

So, in what way can a medical device manufacturer prepare for a medical device examination? I want to present the ultimate guide to medical device inspection, which I believe is going to live up to just what I am calling it: the ultimate guide to medical device inspection.

The basis to a medical device inspection is just one mantra: prepare, prepare and prepare. I already know it and I don’t need you to tell me this, you may say. But how to prepare and what to prepare for is the question. I will try to make my ultimate guide to medical device inspection as comprehensive as I can and will try to shed as much light on as many areas of it as I can, while trying to keep it simple.


Let us begin at the beginning. Some medical devices are designed newly. Many build on what is already there in the market and some are completely off the block. The first step to my ultimate guide to medical device inspection is to understand this aspect of a medical device. Is your device a new one or is it being developed based on an existing device’s core? Many devices alter or extend an existing one to stretch its uses to a new or untapped market. The entire nature of the medical device inspection can depend on this nature of the medical device. So, classifying your medical device into its right slot is the first step in this ultimate guide to medical device inspection. Conceptualizing what your medical device is like is half the work done.


Regulations are at the heart of medical device inspections. All inspections look primarily for the extent of compliance to regulations. In perhaps no other industry is regulation of such vital importance than in the field of medical devices. Getting the regulations right is the foundation of a successful medical device inspection and quite easily qualifies in the ultimate guide to medical device inspection. Companies have enormous resources in the form of FDA literature (or that of other regulatory bodies if the product is marketed in those jurisdictions) and expert guidance.

My sincere exhortation: please do not hold back your purse strings in this most important of areas. If you try to economize and satisfy yourself that you have saved a few dollars here, think of what you will be required to cough up if your device fails to meet regulatory standards. The penalties are of such order that you may even have to shut shop like so many others that have met the same fate. Make sure the regulations are adhered to each and every stage. The consequences of staying compliant are simply too many and all of them are of a positive nature.

Keep a very sharp eye on Design Controls

Design Controls constitute the next point in the ultimate guide to medical device inspection. This is another of the areas in which the FDA is unsparing when it comes to penalizing medical devices companies that don’t meet the requirements. Learn all the intricacies of Design Controls and understand the criticality of documentation in Design Controls. In addition to helping you to meet regulatory standards, it also makes your own life easier. Documentation enables you to quickly track any activity that the inspector may want to examine. It helps you guarantee and assure your activity at every stage. This diagram is neatly indicative of what the FDA expects the Design Control flow to be like:

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New Cancer Vaccine Shown to Be {100% Effective} in Mice With Aggressive Melanoma

A second group was given both of these, plus the chemical Diprovocim added to the ovalbumin injection, as a means to stimulate the immune system into action.

A new cancer vaccine involving an immunotherapy drug and a chemical that boosts its efficacy has just shown a 100% success rate in treating melanoma in mice, according to a new study.

In an especially promising development, the researchers were even able to show their new therapy can fight cancer recurrence down the track, which could mean fewer relapses in the future.

“This co-therapy produced a complete response — a curative response — in the treatment of melanoma,” says one of the researchers, Dale Boger, from the Scripps Research Institute in California.

“Just as a vaccine can train the body to fight off external pathogens, this vaccine trains the immune system to go after the tumour.”

The researchers, from Scripps and the University of Texas Southwestern Medical Center, first screened around 100,000 compounds to look for one that could help them boost the effectiveness of a cancer immunotherapy drug.

Eventually they found a chemical called Diprovocim, which binds to an immune receptor in both humans and mice called Toll-like receptor; the next step was to start testing how this compound could aid the treatment of tumours in mice.

The researchers used a group of mice with an aggressive form of melanoma genetically engineered to contain ovalbumin, a common marker researchers can use to study immune responses in cancer, since it acts as an antigen — it triggers an immune response in the host.

All mice were given a cancer immunotherapy drug called anti-PD-L1, which is meant to prevent tumour cells from evading the host’s immune system, and were then split into three groups of eight.

One group got only anti-PD-L1 and an injection of ovalbumin, the latter of which was meant to train their immune systems to recognise the tumour as an intruder.

A second group was given both of these, plus the chemical Diprovocim added to the ovalbumin injection, as a means to stimulate the immune system into action.

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Medical Wearable Devices Health Technology [Fads or the Future]

The fitness wearable company has adopted Google Cloud for Healthcare application programming interfaces (APIs) in a bid to make data sharing more secure.

The wearable health technology craze looks like it’s here to stay but some devices are proving more useful to the medical industry than others. Which of the most talked about devices are fads and which could be the future?

As the wearable health technology market continues to grow it can be hard to distinguish the trendy consumer devices from those with useful medical applications. From the debate over smart watches to the latest wearable MRI scanner, here’s a roundup of some of the most talked about wearables. Many of them are pointing the way to the future of patient care.

wear electronics

In the ever growing wearable health technology market, Fitbit is arguably the most well-known brand. Extremely popular with consumers, fitness tracking Fitbit watches are not a favourite among medical professionals due to claims that the patient data collected is not accurate enough for medical assertions to be made. However, Fitbit remains determined to break into the healthcare market and partnered with Google earlier this year to improve the ability of its devices to share data with medical professionals. The fitness wearable company has adopted Google Cloud for Healthcare application programming interfaces (APIs) in a bid to make data sharing more secure.

The more medically trusted smart watches include the FDA-approved Empatica smartwatch, called Embrace, which is designed to monitor seizures. The AI-powered device uses advanced machine learning to check for grand mal or generalised tonic-clonic seizures and can send instant alerts to caregivers.


Continuous glucose monitors (CGMs) are becoming increasingly popular with diabetic patients, who can wear the devices day and night to keep an eye on their glucose levels. The popularity of the devices lies in the fact that a patient can view their glucose levels with a quick glance and only have to use a finger prick blood test twice a day to check that the readings on both devices are similar.

Real-time glucose levels help patients make more informed choices about the types of food, physical activities and medication they require throughout the day. CGMs work by using a tiny sensor inserted under a patient’s skin which tests interstitial glucose levels every few minutes and sends this information to a monitor or smartphone. Patients receive alerts when their glucose levels need to be adjusted.

Devices like the Dexcom G6 are popular because they claim to negate the need for patients to use finger sticks.

Diagnostic wearables

No matter how advanced healthcare is becoming there is always an occasion when healthcare professionals just aren’t sure what is wrong with a patient. This is where diagnostic wearables come in.  Australian National University (ANU) researchers recently developed optical sensors that can be used in wearable medical devices to diagnose various diseases in real-time. The sensors measure very small concentrations of metabolite gases, which are emitted through human skin and breath, and use these measurements to detect biomarkers which can indicate a variety of diseases.


Other new diagnostic wearables include body-worn sensors that can assess gait and potentially detect Alzheimer’s disease early. Diagnostic technologies like this definitely have a future as the healthcare industry continues to look for ways of diagnosing chronic conditions earlier.

Cardiac monitors

Wearable imaging

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Medtech firms gets personal with [digital twins]

What started as an evolution is accelerating toward more of a revolution.

Using this “digital twin” that mimics the electrical and physical properties of the cells in patient 7497’s heart, Meder runs simulations to see if the pacemaker can keep the congestive heart failure sufferer alive – before he has inserted a knife.

The digital heart twin developed by Siemens Healthineers (SHLG.DE) is one example of how medical device makers are using artificial intelligence (AI) to help doctors make more precise diagnoses as medicine enters an increasingly personalized age.

The challenge for Siemens Healthineers and rivals such as Philips PHL.AS and GE Healthcare is to keep an edge over tech giants from Alphabet’s (GOOGL.O) Google to Alibaba (BABA.N) that hope to use big data to grab a slice of healthcare spending.

With healthcare budgets under increasing pressure, AI tools such as the digital heart twin could save tens of thousands of dollars by predicting outcomes and avoiding unnecessary surgery.

A shortage of doctors in countries such as China is also spurring demand for new AI tools to analyze medical images and the race is on to commercialize products that could shake up healthcare systems around the world.


While AI has been used in medical technology for decades, the availability of vast amounts data, lower computing costs and more sophisticated algorithms mean revenues from AI tools are expected to soar to $6.7 billion by 2021 from $811 million in 2015, according to a study by research firm Frost & Sullivan ww2.frost.com.

The size of the global medical imaging analytics software market is also expected to jump to $4.3 billion by 2025 from $2.4 billion in 2016, said data portal Statista www.statista.com.

“What started as an evolution is accelerating toward more of a revolution,” said Thomas Rudolph who leads McKinsey & Company’s www.mckinsey.com pharma and medical technology practice in Germany.


For Siemens Healthineers and its traditional rivals, making the transition from being mainly hardware companies to medical software pioneers is seen as crucial in a field becoming increasingly crowded with new entrants.

Google has developed a raft of AI tools, including algorithms that can analyze medical images to diagnose eye disease, or sift through digital records to predict the likelihood of death.

Alibaba, meanwhile, hopes to use its cloud and data systems to tackle a shortage of medical specialists in China. It is working on AI-assisted diagnosis tools to help analyze images such as CT scans and MRIs.Siemens Healthineers, which was spun off from German parent Siemens (SIEGn.DE) in March, has outpaced the market in recent quarters with sales of medical imaging equipment thanks to a slew of new products.

But analysts say the German firm, Dutch company Philips and GE Healthcare, a subsidiary of General Electric (GE.N), will all come under pressure to prove they can save healthcare systems money as spending becomes more linked to patient outcomes and as hospitals rely on bulk purchasing to push for discounts.

Siemens Healthineers has a long history in the industry. It made the first industrially manufactured X-ray machines in 1896 and is now the world’s biggest maker of medical imaging equipment.

Now, Chief Executive Bernd Montag’s ambition is to transform it into the “GPS of healthcare” – a company that harnesses its data to sell intelligent services, as well as letting smaller tech firms develop Apps feeding off its database.

As it adapts, Siemens Healthineers has invested heavily in IT. It employs some 2,900 software engineers and has over 600 patents and patent applications in machine learning.

It is not alone. Philips says about 60 percent of its research and development (R&D) staff and spending is focused on software and data science. The company said it employs thousands of software engineers, without being specific.

Dont try to miss this Digital heart twin developed by Siemens Healthineers https://reut.rs/2wwZbVR