MDM Projects

IEC 60601: Product Safety Standards for Medical Devices

admin — Thu, 11 Feb 2021 07:38:20 +0000

MDM Projects
IEC 60601: Product Safety Standards for Medical Devices

IEC 60601 is a generally recognized set of international guidelines for the fundamental protection and performance of electrical medical devices. It deals with the basic safety and essential performance requirements of medical electrical equipment, and serves to ensure that no single electrical, mechanical, thermal or functional failure shall pose an unacceptable risk to patients and/or operators.

Compliance with the current version of medical devices 60601 must be shown by by all new and existing medical devices. We give the following strategies to help you hit your target audiences, from growth all the way through the analysis of your Risk Management File.

IEC 60601 helps ensure the safety and reliability of electrical and electronic medical devices. To help ensure that the medical devices and products are in accordance with IEC 60601 requirements & ready for shipment to global markets. We leverage our product certification and Safety/EMC expertise.

MDM projects offer a full suite of medical device development and certification. We ensure that you comply with the mandatory IEC 60601 product safety standards recognized worldwide. Our services range from product design and assessment of prototypes (POC) to structured compliance testing.

Different elements of the development cycle

From the beginning of the project, MDM projects will assist you in deciding which requirements apply to your device, reviewing the design specifications for enforcement, and implementing an effective risk management program. During their first phases of medical device development and design, we also provide additional support and feedback to start-up companies. We ensures that barriers to entry are overcome rapidly and a strong regulatory and go-to-market plan is established.

Risk management

In all areas of product creation, from concept consultation, complete product safety testing, and completion of a Declaration of Compliance (DoC), to collection and analysis of the Technical File, we offer unbiased third-party support. Our experts provide you with consultative advice and input during the entire product development process. We have world-class experience in electrical and electronic medical device research, so you can be confident in putting your product on the market.

Certification and marking

The IECEE CB certification meets most of Europe’s CE labeling criteria for the protection of medical and electronic equipment and suggests that you only need to test your product once at a single venue.

Conclusion

Our safety experts understand the difficulty of global export safety testing of medical products and support manufacturers with 3rd party testing, county representation, product localization, and more to achieve accelerated market speed for successful product launches.

IEC 60601: Product Safety Standards for Medical Devices
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FDA Regulation of Medical Devices

admin — Thu, 11 Feb 2021 06:47:29 +0000

MDM Projects
FDA Regulation of Medical Devices

In the area of medical technology, it is of uppermost importance to be keen in FDA regulation of medical devices.

When you introduce technological advancements and developments to the medical device market, first your device must undergo all the required regulations and legislations in order that the requested safety and efficacy standards required by the law are met.

Medical device regulations

The Food & Drug Administration (FDA) oversees medical devices in the USA with the goal of ensuring the safety & efficacy of the devices. This service is covered by the Centre for Instruments and Radiological Protection (CDRH).

FDA categorizes medical devices three risk-based grades, i.e. class I, II, and III. medical instruments. The least associated risk will be in Class I devices and the highest will be in Class III devices. As a result, from Class I to Class III devices regulatory authority increases.

Different types of FDA regulations

The following specific regulations must be complied with by US-based manufacturers & distributors and understood one by one

Premarket Notice 510(k)-21 CFR Part 807
Subpart EPremarket Approval (PMA)-21 CFR Part 814
Investigational Product Exemption (IDE) for clinical trials-21CFR Part 812
Quality System (QS) regulation 21 CFR Part 820
Labeling requirements-21 CFR Part 801
Medical Device Reporting (MDR)-21 CFR Part 8032
Quality System (QS) regulation 21 CFR Part 820

In this respect, most Class I devices are exempted from the submission of 510(k) premarket notification, while the majority of Class II devices are submitted for premarket notification. On the other hand, the Premarket Approval Application (PMA) is required for Class III devices and other Class III devices exempted from the PMA are required to apply a 510(k) notification to the FDA.

Conclusion

For more details regarding medical devices FDA regulations,

you can link to the FDA website .

In any case, you must certainly get a profound overview of the FDA regulations for medical devices before you start your medical product development.

Our organisation can help you in designing FDA Class II and Class III systems for tracking, diagnostics & imaging, wearable health, and telemedicine, as we have hands-on engineering expertise. In addition, we have HIPAA-compliant engineering solutions and have the appropriate IEC 60601-1/2/6, IEC 62304, 510K and ISO 13485 process expertise.

We are happy to assist you with your next breakthrough innovation.

FDA Regulation of Medical Devices
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Growth of Mobile Applications in Healthcare

admin — Tue, 19 Jan 2021 13:18:22 +0000

MDM Projects
Growth of Mobile Applications in Healthcare

Nowadays, it is difficult to imagine an ordinary person without a mobile device. The Internet has become available everywhere thanks to Wi-Fi and affordable cellular rates, so you can now stay online while at work, school, on the road, on vacation and several other locations. As a company it is vital to connect to the target audience in the space where they spend most of their time, and this is definitively the mobile Internet.

Nowadays clients do not want to waste time waiting for a response from a call centre of a medical health care facility in order to receive the requested services. In addition, for some clients it is inconvenient to share their medical condition or some of their medical history on a phone call in order to get appointed to the clinic. It is the mobile application that will save future visitors to a health care facility from unnecessary inconvenience in order to get appointed.

MDM is one the best medical device software development companies that provide a full range of mobile/tablet application development services to medical centers – from analysis and concept development to practical implementation and implementation.

Why are mobile medical apps profitable for medical centers?

Increased efficiency – Having all the necessary patient information and reference materials always at hand, the specialists of the clinic or medical center will be able to see more patients at the same time and pay more attention to each of them, which means better service.
It saves time for your staff – You can create a mobile application for the clinic, which will be integrated with a centralized database. This enables that every doctor can easily view the patient’s electronic medical records from a tablet or smartphone and make new entries during or after a patient’s visit.
Enhanced patient’s awareness- A good idea to send patients appointment reminders, regular news alerts, promotions, special offers and more, is through a mobile app specifically developed for the medical center that is installed on the patient’s mobile device.
Customer loyalty – No doubt, people will choose those clinics where they will have full and convenient access to all their medical data and where they can get all the important information easily, make an appointment or view test results without leaving their home.

MDM has experience in developing mobile applications for medical purposes. We offer to develop a medical mobile application for Android/tablet. Development of mobile/tablet applications for medical centers is a good way to improve the quality of services, stand out from competitors and gain customer confidence. We will be glad if our experience and knowledge will help you when creating projects related to human health.

Our own service department makes it possible to more fully and widely meet your needs, providing service, warranty and post-warranty for Medical Device development services as well as software development services.

Growth of Mobile Applications in Healthcare
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Case Scenarios of Common Mistakes Made During Medical Devices Development

admin — Tue, 19 Jan 2021 13:16:53 +0000

MDM Projects
Case Scenarios of Common Mistakes Made During Medical Devices Development

Case scenario 1 :

Reliance on MedicalAC/DC adaptor with standard connector as means of protection against electrocution.

Problem:

Patient/operator uses standard ITE AC/DC adaptor.

ITE AC/DC adaptor does not provide medical grade protection thus no such reliance is accordable.

Possible solution:

Use of Medical AC/DC adaptor with unique connector.

Employment of engineers with medical device design.

Requirements of IEC 60601-1(medical devices standard)CL. 4.7 are not fulfilled, leading to fail verdict in the report.

Possible solution:

Employment of engineers with medical device design.

Following good engineering practices.

Seek guidance from testing house.

Case Scenarios of Common Mistakes Made During Medical Devices Development
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Most Common Medical Devices Development Mistakes

admin — Tue, 19 Jan 2021 13:14:56 +0000

MDM Projects
Most Common Medical Devices Development Mistakes

We are convinced that all of you, dear readers of this blog, are experts in your specific fields. However, even the most experienced professionals not seldom underestimatethe most common development mistakes, such asthe absence of the consultation about the knowledge and the expertise of specialists inother disciplines. Therefore, it is of uppermost importance to share expertise among experts from different fields and collaborate with different departments, such as for example between R&D and Regulatory Affairs already from the very first steps in your product development process in order to achieve the requested goal.

During the past years MDM projects was involved in several gap analyzis in startups and large companies and faced different situation that led the company into a bottle neck situation. For example, we met a situation when the certification department got involved in medical development only at the final stage, instead from the very beginning. This situation harmed the project not only financially, but also led to a delayed time line.

Example A:

A start-up company with an innovative medical device and great market potential, implemented medical devices for intendancy of use “continuous monitoring device”. The device included WIFI/BLE communication and transmitted real time data to TV nurse station. MDM projects performed a gap analysis and found that the device would have been rejected by the FDA because of a missing build-in information panel. A mistake that could have cost the company half a year of development delay.

The medical device development request compliance to medical certification 60601-1/2, not all specialist has enough experience with medical development design.

And what about Biocompatibility requirements?

Dide you found the appropriate solutions for your mechanics and plastics?

and what about sensors that have direct skin contact? What about ESD compliance for sensors?…….

You see, there are many questions to be answered already during the first design stage.

Example B:

A company developed a medical device for the treatment of Alzheimer disease. The medical device was at 60601 certification stage. However, the medical device failed leakage current test (the leakage current was more than 350uA). MDM projects proposed several solutions to solve this specific problem., For this, MDM projects added an external transformer and fixed this problem. However, this problem could have been avoided if the gap analysis was done by an expert in regulatory affairs already from the very first beginning.

Another critical area of medical device development is conformity for radiation immunity and emissions.

Example C:

A company that development a home use hair removal device loosed six months in trails to finalize compliance for radiation immunity and emissions because of mistakes in the first stage design. Fortunately, this problem was solved by adding inlet filters improving traces routing, improving flayback and switching circuit.

However, during the gap analyses of the same device MDM projects found non conformity for standby power requirements.

MDM projects believes that one of the most important stages of medical devices development is the initial stage in which specialists from all areas should participate. All issue can be solved by applying

Most Common Medical Devices Development Mistakes
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Medical Device Development And New MDR Regulation

admin — Tue, 19 Jan 2021 13:13:02 +0000

MDM Projects
Medical Device Development And New MDR Regulation

What Is Medical Device Development

Medical device development involves all stages from the conception of a product to releasing it in the market. The product may be an advanced x-ray machine, CT-Scan, MRI or any other medical device. Launching a medical device is not an easy job. It involves the formation of an optimally operating instrument followed by layers of regulations to be considered.

Need Of A New Medical Device

The need or demand of a new medical device may be for an entirely new way of diagnosing diseases or examining patients that are not available before. It may also be due to the up-gradation of the present equipment to get better and more reliable results or make things easier for health care providers and patients.

Stages Of Medical Device Development

The exact procedure differs from place to place according to the regulatory law applied in the specific country. It also depends upon what type of device is under consideration. Generally, the whole process can be divided into five stages for design control and obtaining an effective and safe device for use:

Initiation and risk analysis
Concept formulation and feasibility
Design development and validation
Product launch
Post-launch assessment

There is strict regulation for the approval of medical devices to be launched in the market for public use to ensure the user is at no risk while under examination of these devices.

Duration Of Medical Device Development

The time required in the complete development of a medical device depends on the type of device. According to the FDA, there are three classes of devices.

Class 1

These are the devices that are quickest to get into the market. Electric toothbrushes and oxygen masks are examples that are included in this class. The approval procedure completes usually within one week.

Class 2

This class comprises 43% of the devices and have a moderate risk factor. These devices have an average time of three to six month to get approved. The anesthesiology devices take the longest time while the toxicology devices are approved more quickly.

Class 3

Almost 10% of the devices belong to this class and are of the high-risk level. These devices include defibrillators, implanted prostheses and cochlear implants. It can take eight months to a year to approve this equipment as there is a more strict system of checking and evaluation for these devices.

Medical Device Development Services

Many companies offer services if you want to launch or develop any medical device. You can get guidance and professional help in all the stages of device development.

Medical Devices Regulation

The medical device regulation is a mechanism to evaluate the significant risk factors involved in using medical devices. These regulations aim to identify problems timely and correct them appropriately. Every region of the world has its regulatory authorities. As such, the European Union has its laws for medical devices regulated in Europe, which is very broad. The regulations usually cannot quickly and easily be understood. It’s something that takes some time to learn, analyse and prepare for.

The upgraded text of regulatory laws has parts involving more scrutiny of technical documentation and product safety and performance assessment. It has brought stricter checking of clinical evaluation and post-market clinical follow-up procedures. This regulation also ensures better traceability of devices through the supply chain system and distribution. Before diving into the device development process, it is vital to fully understand all the related regulations and implement them correctly. In this way it is ensured that the product is heading into the right direction from a regulatory point of view.

Medical Device Development And New MDR Regulation
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Medical Device Certification in the Age of MDR

admin — Tue, 12 Jan 2021 05:21:16 +0000

MDM Projects
Medical Device Certification in the Age of MDR

Introduction to medical devices standards
What is harmonization and what is the status of harmonization with MDR?
So, what has changed?
Lessons learned from recent submissions to NBs
Common mistakes made during medical device development

Introduction to medical devices standards

BASIC SAFETY

Freedom from unacceptable RISK directly caused by physical HAZARDS when ME EQUIPMENT is used under NORMAL CONDITION and SINGLE FAULT CONDITION

ESSENTIAL PERFORMANCE

Performance of a clinical function, other than that related to BASIC SAFETY, where loss or degradation beyond the limits specified by the MANUFACTURER results in an unacceptable RISK

MEDICAL ELECTRICAL EQUIPMENT (ME EQUIPMENT – medical device)

Electrical equipment having an APPLIED PART or transferring energy to or from the PATIENT or detecting such energy transfer to or from the PATIENT and which is:

Provided with not more than one connection to a particular SUPPLY MAINS; and
Intended by its MANUFACTURER to be used:
(a) In the diagnosis, treatment, or monitoring of a PATIENT; or
(b) For compensation or alleviation of disease, injury or disability
Know your standards
Start with terms and definition
Until you know terms and definitions by heart always keep them open while reading
Ask testing houses for guidance
Not everything intended for hospital use should be certified towards IEC 60601-1
Talk to NBs
Perform FDA pre-submissions

What is harmonization?

IEC and ISO standards turned EN
Are very similar to international standards
Explicitly published in the EU Official Journal
These standards are uniform throughout Europe

In short, all harmonized standards which are used should cover the Essential Requirements. If gaps still remain, they must be filled with other verification.

What is the status of harmonization with MDR?

In June 2019, the European Commission issued the draft standardization request as regards medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746.

This request identified the first batch of standards for consideration for harmonization to the MDR and the European In Vitro Diagnostics Regulation (IVDR). There are a large number of standards in the mandate:

Some 57 revisions and six totally new standards for the MDR.
30 revisions and four new standards for the IVDR.
With some overlap, there’s a total of 79 separate documents in the work program.

Priorities are being given to a handful of key standards, specifically those on quality systems (ISO 13485), risk management (ISO 14971), biocompatibility (ISO 10993-1), clinical trials (ISO 14155), and labelling (ISO 15523), including labelling for devices containing phthalates (ISO 15986).

So, what has changed?

On the paper – nothing.

In practice the NBs are scared of the transition and preferring to be on the safe side.

Some are even trying to be more righteous than the Pope.

Sorts of outrages requests such as:

Medical Device with peristaltic pump should comply with Machinery Directive
Device should comply with international standard currently in final draft stage.
Rule 11 – All active devices intended to administer and/or remove medicines, body liquids or other substances to or from the body are in Class IIa, unless this is done in a manner:

— that is potentially hazardous, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application in which case they are in Class IIb.

Lessons learned from recent submissions to NBs.

Be very careful when consulting the current directives’ harmonized standards list on the Europa website. For every standard you expect to use, check carefully if there is a later version published by ISO or IEC, and consider using that instead.
Don’t assume that anything on the current Medical Device Directive (MDD), In Vitro Device Directive (IVDD), and Active Implantable Medical Device (AIMD) lists of harmonized standards will carry over to the MDR/IVDR. That should be verified.
If there is a discrepancy, talk to your Notified Body about it. Check that they are comfortable with you going to the later version (or, if you have test data against the harmonized version, check that they will accept it).
Keep an eye on the ISO website, so you can see what changes are coming.
Finally, you should also have communication with your national standards body about what is happening. There will be local experts who are involved in the development of new ISO documents. They should be able to tell you what’s planned and when new standards are likely to be published.

Lessons learned from recent submissions to NBs.

Use latest EN version of 14897 there are some very important deviations from the international version.
(requirements from the international version are in bold)

Users shall be informed about the residual risks. This indicates that the information given to the users does not reduce the (residual, some say not only residual) risk any further.
residual risk is defined as the risk remaining after application of risk control measures.
regards “information for safety” to be a control option.

Should you use BS EN ISO 14971:2019 or the older version?

According to BSI shop BS EN ISO 14971:2019 replaces BS EN ISO 14971:2012, on the other side it is not harmonized.

As I see it – it is part of the state of the art and the last revision should be used. Some very important definitions have been added. One of them is term Benefit.

More attention is given to the expected benefits of using the medical device. The term benefit-risk analysis has been aligned with terminology used in some regulations
The method for evaluating the overall residual risk and the acceptance criteria are to be defined in the risk management plan
The review before commercial distribution of the medical device concerns the execution of the risk management plan. The results of the review are documented as the risk management report.

Medical Device Certification in the Age of MDR
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