Dear Valued Clients and Partners,
As we embrace December, the final chapter of a year marked by transformation, we at Access-2-Healthcare are delighted to connect with you. Hope everyone closes the year on a high.
We sincerely appreciate the trust and partnership you have shown us, not just in the past year but these 9 years. With our 10th year approaching, let’s continue to drive innovation, achieve success, and make meaningful progress in the field of medical devices as we close this year and look forward to the future.
FDA is issuing this guidance to provide recommendations for predetermined change control plans (PCCPs) tailored to artificial intelligence (AI)-enabled devices. The recommendations in this guidance are intended to support iterative improvement through modifications to AI-enabled devices while continuing to provide a reasonable assurance of device safety and effectiveness.
Learn More ⟶Anvisa has updated its understanding of the Operating Authorization for storage facilities in special warehouses and importers of medical device components. The measure applies to finished products subject to regularization by the Agency, resulting from the recent publication of Collegiate Board Resolutions (RDCs) 860/2024 and 939/2024.
Learn More ⟶The Medical Device Authority (MDA) of Malaysia has released the development timeline for the MeDC@St3.0 project, spanning from 2023 to 2027. This ambitious initiative aims to enhance the country’s medical device regulatory framework, reaffirming MDA’s commitment to ensuring the safety and efficacy of medical devices in Malaysia. The timeline outlines key milestones and phases, offering stakeholders a clear roadmap of the project’s progression and upcoming developments.
In Q4-2024, the project has reached a significant phase, featuring the presentation of its progress and the finalization of the Business Requirement Specifications (BRS) based on the collected input.
Regulation (EU) 2017/745 on medical devices (MDR):
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR):
UK approved bodies:
Regulations 2017/745 and 2017/746 on medical devices and in vitro diagnostics aim to ensure the availability of safe and effective devices. This should protect patient safety and public health while making the sector more competitive and supporting innovation.
Learn More ⟶New legislation is being laid in Parliament today that will address the research sector’s need for a more efficient, streamlined and adaptable regulatory framework for clinical trials. It will make the UK a more attractive place for innovators to conduct important research and will help to get potentially life-changing new treatments to patients and the NHS as quickly as possible.
Learn More ⟶Centinel Spine®, LLC (“the Company”), the leading global medical device company focused exclusively on treating cervical and lumbar spinal disease with the most complete and clinically-proven total disc replacement (TDR) technology platform in the world (prodisc®), today announced the recent release of a landmark study supporting the long-term clinical success and durability of its prodisc L Lumbar Total Disc Replacement (LTDR) technology.1 The study has been posted electronically prior to print publication by The Journal of Bone & Joint Surgery, considered the gold-standard in peer-reviewed orthopedic scientific information.
Learn More ⟶R-Bridge Healthcare Fund (“R-Bridge”), an affiliate of CBC Group, Asia's largest healthcare-dedicated asset management firm, today announced the closing of a non-dilutive growth financing facility of up to US$50 million for Human Investments Ltd.
Learn More ⟶With many health and beauty problems in today's society being caused by aging and cell deterioration, Nihon Joju Clinic was born, a clinic that operates under the concept of "rejuvenating health from cells", using the latest medical technology for treatment. Recently, Dr. Egoshi is preparing to fly to Thailand to promote new innovations with advanced technology to Thais who care about their health and beauty.
Learn More ⟶A new class of magnetism called alter magnetism has been imaged for the first time in a new study. The findings could lead to the development of new magnetic memory devices with the potential to increase operation speeds of up to a thousand times.
Learn More ⟶The crux of prototyping is broken down to two key aspects
- Ability to understand and translate clinical need
- Engineering capability
To understand and translate Clinical Need does more than just satisfying the clinician or the patient. It helps to reduce iterations, and therefore reduces time and effort wastage. By listening and considering feedback, a better form factor, better device usability are likely outcomes.
Engineering capability is based on the ability to have 1. Engineering tools and equipment. 2. Actual engineers that knows how to operate the tools, and engineering design skills.
Between the two, having engineering capabilities appears to be less of an issue, but it can be when the engineers are good in one aspect of engineering and therefore one part of the device, but not too good with others. Furthermore, the ‘capabilities’ here refer to the engineering resources in touch with you, not their suppliers.
A recent case is exactly, that, where the client is endlessly waiting for a (competent) supplier of the engineering company that was contracted, because of the lack of commitment from the supplier. What would be done in 3 months had stretched to 8 months. Does it matter? Yes! Because in the other 5 months you are eating up cash in other aspects. So speed indeed is the essence.
Therefore, some of the first checks to hunt for the right prototyping group
- If they are listening to you and considering your feedback, even when you don’t appear to make sense.
- Have the necessary engineering tools
- Ensure engineers are capable and not just their suppliers
- Commitment to your project, or else the project will drag on endlessly.
Still clear as mud?
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Duphat Dubai Dubai World Trade Center, Dubai 07 - 09 January 2025 Click Here ⟶ |
Hong Kong Baby Products Fair Expo Galleria, Hong Kong Convention and Exhibition Centre, Wan Chai, Hong Kong 6 - 9 January 2025 Click Here ⟶ |
Pharmatech Expo 2025 – Bengaluru Bengaluru, India 8 - 10 January 2025 Click Here ⟶ |
ESTHEC JAPAN Tokyo Tokyo, Japan 15 - 17 January 2025 Click Here ⟶ |
Pak Pharma & Healthcare Expo Lahore Expo Centre Lahore, Pakistan 20 - 22 January 2025 Click Here ⟶ |
Lääkäripäivät Helsinki Helsinki, Findland 22 - 24 January 2025 Click Here ⟶ |
Wearable Expo Tokyo, Japan 22 - 24 January 2025 Click Here ⟶ |
22nd Annual Medical Expo Floria, USA 25 January 2025 Click Here ⟶ |
Arab Health Dubai Dubai World Trade Centre, Dubai 27 - 30 January 20255 Click Here ⟶ |
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