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Wearable Medical Devices
The medical device industry changes constantly as new innovations and advancements are made in development, medical IT, and healthcare. Our medical device blog features expertise from the Sterling Medical Devices team and the latest information and regulation changes in the medical device industry that you should be aware of.
The healthcare and wellness industry is shifting toward regulated, personalized, and monitored healthcare. In a short period, mobile devices have skyrocketed in use. With these advancements, wearable devices such as - well-being tools, health monitors, fitness devices, and disease prevention devices are becoming more vital in the healthcare field.
Today, artificial intelligence, robots, sensors, big data, radar technologies, IoT, and digital wearables can manage and prevent diseases. They can estimate blood pressure, body temperature, heart rate, and respiration and indicate risks such as declining health, worsening sickness, and other threatening situations like - increased blood pressure or breathing problems.
We have an experienced team of people who help companies /medical device manufacturers in streamlining their pathways for market approval. We have expertise in FDA & EUMDR regulatory compliance and also put efforts into error free deliverables. Feel free to contact us for any Wearable medical device regulatory assistance.
How can wearable devices improve health?
The last five years have seen an increase in digital wellness wearables that can collect data in real time and reveal the physical and chemical properties of the body to evaluate wellness. Wearables are small electronic devices that, when placed on your body, can help measure temperature, blood pressure, blood oxygen, breathing rate, sound, GPS location, elevation, physical movement, changes in direction, and the electrical activity of the heart, muscles, brain, and skin.
How is Wearable Technology used in Healthcare Nowadays?
Tracking Health Status
With a health monitoring device, doctors can track and measure their patient's vitals in real-time such as heart rate, ECG, blood pressure, body temperature, etc.; the gadgets can transmit the necessary patients' data to the doctors for further examination.
Therapeutic Treatment
Patients with chronic diseases can get timely treatment once their metrics exceed the level, e.g. getting automated insulin pumps or medications. Moreover, with these devices, doctors can better adjust the patients' therapy by monitoring their patients' conditions.
Health and Activity Tracking
Apart from doctors monitoring their patients' states, wearable gadget users can track their health status and follow a healthy lifestyle. This includes sleep pattern tracking, heart rate monitoring, blood oxygen concentration or SpO2 monitoring, calorie tracking, steps, swimming tracking, etc. In case of any irregularities, they can seek consultation from a qualified doctor to take preventative action against any disease development.
Other Uses
Wearables can also help in the diagnosis, screening, and monitoring of psychological disorders like depression. It also improves patient management efficiency in hospitals. In addition, wireless transmission in wearable systems allows researchers to develop new types of point-of-care diagnostic tools.
Top 5 Wearable Devices in Healthcare
Wearable Fitness Trackers
Some of the simplest and most original forms of wearable technology, wearable fitness trackers, are devices equipped with sensors to keep track of physical activity, heart rate, oxygen level, blood pressure, etc. These provide wearers with health and fitness guidance by syncing to various smartphone apps. Wearers can get a good idea of how healthy they are. Few wearable fitness monitors support the setting of daily fitness goals and show the progress made on those goals.
Smart Health Watches
Smartwatches allow users to perform tasks they normally do on their phones - read notifications, send simple messages, and make phone calls, while also offering some of the exercise and health-tracking benefits of fitness trackers. A smartwatch sends you a notification that you need to do more exercises, or it can alarm you if you're exerting too much effort. Having a smartwatch that can effectively monitor your heart rate is a great way to avoid injuring yourself.
Wearable ECG Monitors
Wearable ECG monitors are on the cutting edge of consumer electronics, and what sets these monitors apart from some smartwatches, is their ability to measure electrocardiograms or ECGs. Some personal-use ECG devices have built-in screens so you can see your heart rhythm on the monitor. Other devices connect to a smartphone or computer application where you can record, view, store, and share your ECG readings.
Wearable Blood Pressure Monitors
Wearable blood pressure monitors are devices that you wear and that can easily and quickly measure the levels of your blood pressure. We are all used to those traditional devices that you can use now and then remove from your hand until you decide to use them once again, but things are changing in this industry, and people are coming up with all kinds of possible solutions. Well, this particular product is one of those possible and better solutions, since you have the opportunity to check your blood pressure wherever you are and without any trouble. All you need to do is have a device on your wrist that can do the measurement for you.
Wearable biosensors
Wearable biosensors are portable electronic devices that enable real-time monitoring and feedback to the user on various biological and physiological indicators. They can provide real-time measurements of various biological parameters, including blood pressure, heart rate, temperature, respiratory rate, and activity levels. They create two-way feedback between the user and their doctor and enable continuous and noninvasive disease diagnosis and health monitoring from physical motion and biofluids.
Read more articles -
FDA 510k Clearance process consulting
CDSCO issues Medical devices importing license
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UKCA marking for medical devices
UKCA stands for United Kingdom Conformity Assessed, and is applied to products placed on the market in the UK. This replaces the CE mark, which – pending changes to legislation - is recognised in the UK until the 30th June 2023. So from this date onwards, medical device manufacturers need to comply with the new UKCA marking regulations.
manufacturers now need to plan for how they will obtain a UK Conformity Assessment mark before 30th June 2023. As many have seen, there have been delays in obtaining the mark, so the quicker manufacturers act, the better.
Operon strategist is medical devices consulting has a good experience in consultation and regulatory expertise for manufacturers and suppliers of medical devices. for any medical device registration process, UKCA marking and licensing you can connect with us.
WHAT ARE THE REQUIREMENTS FOR CE MARKED PRODUCTS IN THE UK?
From 1 January 2021, there are a number of requirements that products marketed as medical devices in Great Britain (England, Wales and Scotland) must comply with:
Certificates issued by notified bodies recognised by the EU will remain valid for the UK market until 30 June 2023.
The EU no longer recognises the UK’s notified bodies.
UK Notified Bodies cannot issue CE certificates (except for the purposes of the “CE UKNI” mark, which is valid in Northern Ireland), and have become UK Approved Bodies.
A new route to market and product marking is available for manufacturers wishing to obtain UKCA marking for medical devices.
From 1 January 2021, all medical devices, including in vitro diagnostic (IVD) medical devices, marketed in Great Britain must be registered with the MHRA. There is a grace period for registration:
Class III and Class IIb implantables, and all active implantable medical devices and IVD List A products must be registered by 1 May 2021.
Other Class IIb devices and all Class IIa devices and Schedule B IVD products and self-testing IVDs must be registered from 1 September 2021.
Class I devices, custom-made devices and general IVDs must be registered from 1 January 2022
Class I devices, custom-made devices and general IVDs that, prior to 1 January 2021, were required to register their devices with the MHRA (i.e. UK-based manufacturers or third country manufacturers with authorised representatives based in Northern Ireland) must continue to register their devices from 1 January 2021.
So what is the difference between what you have to do to place a CE Mark on a product versus a UKCA Mark?
There are two levels to this answer:
The mechanics of UKCA-marking
The regulatory basis for conformity assessment
The mechanics are that a UK Approved Body will need to perform the conformity assessments that formerly the EU Notified Body (NB) would do. It appears that the two UK-based NBs that are able to do the necessary for medical imaging products will become UK Approved Bodies automatically, so not much change there, except that they will need to authorise both a CE mark and (in due course) a UKCA mark (likely at an extra fee). It is not clear whether EU-based Notified Bodies will be allowed, and at what point in time, register as UK Approved Bodies.
Additionally, while the UK standards will be the same in substance and with the same reference as the standards used in the EU, they will use the prefix ‘BS’ to indicate that they are standards adopted by the British Standards Institution as the UK’s national standards body. All references to standards in any regulatory documentation to be submitted for a UKCA assessment would therefore have to be updated with the ‘BS’ prefix.
For Class I & general IVD:
Class I device or general IVD do not third-party conformity assessment. Class, I device manufacturers must self-declare that the device meets the UK MDR criteria. If a class I device has any sterile or measuring functions, the manufacturer needs to approach the UK-approved body for the conformity assessment.
For Class IIa, Class IIb, Class III, IVD:
For Class IIa, Class IIb, Class III, IVD medical devices involvement of a UK-approved body is necessary to undergo a conformity assessment procedure. After approval from a UK-approved body, a manufacturer can declare that devices conform with the UK MDR 2002 and place it on the market.
All class medical device manufacturers must sign a ‘declaration of conformity before placing the UKCA marking on their product. The manufacturer needs to include the name of the UK-approved body if it is involved.
Read more articles -
FDA 510k Clearance process consulting
CDSCO issues Medical devices importing license
get the CE approval with minimal efforts.
For more info please visit
What Does a FDA 510( k) Clearance mean?
Medical devices for human use within the United States must be submitted to the FDA to determine if the product is safe and effective. To do this, in utmost cases a company must compare their product to one formerly cleared by the FDA and give substantiation that their product is “ substantially equivalent ” to the preliminarily cleared( legally marketed) device. To be mainly original, the product must meet criteria for the same intended use, have the same technology or( slightly) different technology but produces similar end results, and be safe and effective.1 Once “pre-market clearance ” is took from the FDA the device can be distributed commercially immediately.
There are important differences between “ cleared ” and “ approved ”. When a medical device is cleared, this means it has experienced a 510( k) submission, which FDA has reviewed and handed clearance. For Class III medical devices to be legally marketed they must suffer a rigorous review and approval process orpre-market approval( PMA).
In the United States, this frequently means submitting a 510( k). A 510( k) is a structured package of information about your device and its performance and safety that you submit to the Food and Drug Administration( FDA) for “ clearance ” before you can deal your device in the U.S. In order to receive clearance from the FDA, your 510( k) will need to demonstrate that your medical device is substantially equivalent to another legally marketed device (called a predicate device).
What Exactly is Substantial Equivalence?
Now that we know what a 510( k) is, let’s talk about the substantial equivalence standard. You ’ll recall from the intro that your 510( k) must show that the new( or modified) device is substantially equivalent to at least one other legally marketed device, called a predicate device. Substantial equivalence looks at the intended use and the technological characteristics of the two devices.
Operon Strategist is a leading medical device consultant providing FDA 510k Clearance process consulting to the customers to register SBU( Small Business Unit), if applicable. Take out the testing demand of the product, creation of the dossier, resolving the queries and after completion of all the conditioning, the customer receives the US FDA 510 k premarket approval. We also help with the establishment enrollment and device listings to make suitable the supply of medical devices in the US.
We helps during the process of submitting operations for class I, II, III medical devices at any stages of the product development. Our team of good experts will successfully prepare and submit FDA medical device regulatory documents for theU.S and international customers. These operations include
510( k) Premarket Notifications
Premarket Approval Applications( PMAs)
De Novo Request( Application)
513( g) Requests for Classification
Investigational Device Exemption Applications( IDEs
Investigational New Drug Applications( INDs)
510( k) Premarket Notifications
Operon Strategist provides answers to related questions
Which groups( Class I, II, and III) do we require an FDA 510( k)?
How many stages consist of the 510( k) application process?
A class I, II, and III device intended for human use, for which a Premarket Approval FDA operation( PMA) isn't needed, must submit a 510( k) to FDA unless the device is pure from 510( k) conditions of the Federal Food, Drug, and Cosmetic Act( the FD&C Act) and doesn't exceed the limitations of exemptions in.9 of the device classification regulation chapters(e.g., 21 CFR862.9, 21 CFR864.9). Technically, under the 510( k) process, the FDA doesn't “ authorize ” medical devices and IVDs; the FDA issues a “ clearance ” or “ Approval ” for deal in the United States. typically, the FDA shall be subject to a provision of 510( k), should manufacturers intend to deal the Class II Medical Devices and some needed Class I and III bias or IVDs on the US market. Apre-market 510( k) approval is also required for already approved medical devices( Predicate) if the manufacturer( s) modifies the technology or changed the intent of device operation in a way that significantly affects patient safety or device performance.
The 510( k) is generally the most effective route to market clearance in the U.S. because you show your device is safe and effective based on this substantial equivalence standard, rather of demanding to present more expansive clinical trial data.
There are three types of 510( k) Traditional, shortened, and Special. This eBook will begin with a general overview of the 510( k) process, including its purpose and benefits. Next, we will explore the Traditional 510( k) and the sections and factors needed in depth. Finally, we will look at the Special and shortened 510( k).
When is a 510( k) needed?
A 510( k) is needed for medium risk devices that have a predicate on the market which can be used to demonstrate the safety and effectiveness of the new device. Meanwhile, a PMA is needed for high- risk or new devices which bear a advanced position of scrutiny to be verified safe and effective.
Complaints
Still, the end user can file a complaint with the FDA or the manufacturer, If a FDA 510( k) cleared medical device isn't performing as intended.
The user or client can also file a complaint with the FDA if it knows that the manufacturer or his representative or distributor is making false marketing claims or incorrectly promoting the performance of their device. This is a straightforward process to insure that medical devices on the market are being held to strict standards to make sure it's being used safely and effectively
Things to Consider
Before choosing a product with a FDA 510( k) clearance, it's important to understand what the product is claiming to do. Similar products may not perform exactly the same due to differences in technology or manufacturing. It's also important to make sure to read the indications for use to know how to use the product properly. Eventually, test data that has been transferred to the FDA should be available to the end user, frequently in a confirmation guide or test report.
Operon Strategist is a medical device regulatory consulting company which provides regulatory advisory & guidance to various manufacturers in the healthcare industry to ensure the strategic development of these manufacturers.
The US Food and Drug Administration has published a largely anticipated proposed rule to harmonize its medical device quality management system( QMS) regulation, 21 CFR Part 820, to the ISO 13485 QMS standard.
FDA’s proposed rule “ would harmonize quality management system conditions for FDA- regulated devices with conditions used by numerous other regulatory authorities around the world, ” the agency countries. Greater alignment of FDA Quality System Regulation( QSR) with ISO 13485, first proposed by the regulator in May 2018, would bring US QMS conditions for medical device manufacturers closer in line with quality system conditions in markets similar as the European Union, Japan and Australia, potentially streamlining medical device registration and compliance processes across the US and other markets.
What's ISO 13485 Quality Management System
How do you manage your Quality Management System? If you're like the majority of the medical device industry, chances are you have a QMS that's a combination of paper- based processes and general purpose tools, approximately held together by a group of people within your company-- generally document control.
It’s important because it's long overdue with the former interpretation being released 13 years before in 2003.
The 2016 standard is veritably much a bridge. What I mean is that this bridge explicitly describes and defines current QMS prospects for medical device companies. Prior to these advances being formally defined and documented in the standard, numerous of the best practices being advised and adopted were veritably ad hoc in nature and frequently sounded to be based on auditor opinions.
Medical device manufacturer should appoint an experienced ISO13485 consultant who can work on all risk class devices. The associations need to cover the safety and risk information during product life cycle as per ISO 13485 demand. As an ISO 13485 medical device consultant, Operon Strategist identify the specific regulatory demand for the product similar as MDR, FDA 510( k) during the perpetration. This helps manufacturer in the further process of CE mark medical device or FDA 510( k) clearance.
An Overview of the ISO 13485 Quality Manual for Life Sciences
The International Organization for Standardization( ISO) is an internal standard- setting group of representatives from public standards associations.
This group maintains a comprehensive set of standards for life sciences associations. These standards are generally referred to as ISO 13485 standards. The current version of ISO 13485( last streamlined in 2020) sets forth major manufacturing and quality guidelines for businesses in largely regulated industries.
To alleviate unforeseen danger and uphold universal quality control standards across the medical device manufacturing industry, an ISO 13485 quality homemade outlines the mission-critical quality control guidelines and QMS conditions needed to keep both users and manufacturers safe.
ISO 13485 Documentation Requirements
By now, you should be veritably familiar with the word “. still, also it did n’t be, if it is n’t proved. ”
Yes, documentation of QMS processes, quality events, and workflows is critically important. occasionally the notion of documentation can produce angst within a company. occasionally the idea of documentation is viewed as overly burdensome and frequently times unnecessary with little value added.
In my experience, utmost companies do produce quite a many burdens and obstacles regarding documentation. And it does n’t have to be this way.
Documentation should be about defining processes and maintaining the records needed to demonstrate these processes are being followed. Documentation is crucial for objective substantiation. Objective substantiation to support your employees through design, development, manufacturing, and support of medical devices. Objective substantiation to demonstrate that conditions are being addressed.
Establishing thorough, yet functional, document operation practices for your business is one of the most important foundational rudiments of a QMS.
Benefits of an ISO 13485 Quality Manual
A comprehensive ISO 13485 quality homemade serves as the nautical design for workers, guests, controllers, and others that come in contact with your life lores incipiency or scale- up. also, an up- to- date ISO 13485 quality homemade ensures that your association’s QMS noway falls below norms.
Another benefit of the ISO 13485 primer is the pledge of increased customer confidence. Some guests will not indeed ask to see further bribes if they've evidence of an active ISO instrument and access to a quality primer. From an functional viewpoint, taking the time to collect this collection of attestation is well worth the time and trouble.
Key elements of an ISO 13485 Quality Policy:
Adapt the policy to the association.
Define a frame for setting your quality objects.
Establish the commitment to meeting all conditions.
Establish the operation commitment.
Communicate the Quality Policy.
insure the regular review of the Quality Policy.
What's the ISO 13485 Quality Policy?
The Quality Policy should be the overall thing of the association, and is written by top operation in order to direct everyone in the association as to how medical devices will be created and delivered to the guests.
This top- position policy is intended to be communicated and understood by everyone in the company, so they can all follow one strategic direction on how product development happens and how conditions will be met. Commitment to quality can also be used throughout the association as a focus on how processes are performed, and as a companion for the quality objects of the association — those main enhancement aims that the company plans to achieve.
Read more articles -
FDA 510k Clearance process consulting
CDSCO issues Medical devices importing license
get the CE approval with minimal efforts.
please visit
Get certification for your medical device globally. Medical device registration in India.
Get Medical Device Registration globally. Also, export and import your medical device product in different countries.
Get Medical Device Registration globally. Also, export and import your medical device product in different countries.
Get Medical Device Registration globally. Also, export and import your medical device product in different countries.