Bring on the Heat!

Seems like summer is on full blast. Do you have any plans for the summer holiday? Whether it is at the beach, in the mountains or with family and friends, this month’s MedTech Gateway from Access-2-Healthcare will help you stay on top of recent developments in medical device technology.


The FDA’s Center for Devices and Radiological Health (CDRH) recognizes the importance of globally harmonized medical device regulatory policy and practices. There is now a page that explains how the FDA collaborates with stakeholders in Japan through the Harmonization by Doing (HBD) initiative, and provides information on programs, resources, and accomplishments.



The Guidance Page has been updated to reflect that the UK government is now aiming for core aspects of the future regime for medical devices to apply from 1 July 2025, including the MDR Transition Plan and templates such as this



The Australian government agreed to extend the deadlines for several medical device reforms underway in Australia because of the impact of the European Union Medical Device Regulations (EUMDR) transition. The extended deadlines would give manufacturers time to obtain an EU MDR certificate before the end of the EU MDR transition on 31 December 2028, and for sponsors to use the MDR certificate to apply to the TGA before 1 July 2029.


Regulation (EU) 2017/745 on medical devices (MDR):

1.  3EC International (Slovakia) – 2265

2.  BSI (Netherlands) – 2797

3.  BUREAU VERITAS (Italy) – 1370

4.  Berlin Cert Pruf (Germany) - 0633

5.  CE Certiso (Hungary) – 2409


7.  CERTIQUALITY S.r.l. – 0546

8.  DEKRA Certification (Germany) – 0124        

9.  DEKRA Certification (Netherlands) – 0344

10.  DNV MEDCERT GMBH (Germany) - 0482

11.  DNV Product Assurance AS (Norway) – 2460

12.  DQS Medizinprodukte (Germany) – 0297 

13.  ENTE Certificazione Macchine SRL (Italy) – 1282

14.  Eurofins Electric & Electronics Oy (Finland) – 0537

15.  Eurofins Product Testing Italy S.r.l. (Italy) – 0477

16.  GMED SAS (France) – 0459

17.  HT Cert (Cyprus) –2803

18.  IMQ (Italy) – 0051

19.  Institut Pro Testovani A Certifikaci (Czech Republic - 1023

20.  Intertek Medical Notified Body AB (Sweden) – 2862

21.  Istituto Superiore Di Sanita’ (Italy) – 0373

22.  ITALCERT SRL (Italy) – 0426

23.  KIWA CERMET ITALIA S.P.A (Italy) – 0476

24.  Kiwa Dare B.V (Netherlands) – 1912

25.  MDC Medical Device Certification (Germany) – 0483

26.  NSAI (Ireland) – 0050

27.  Polskie Centrum Badan I (Poland) - 1424

28.  SGS Belgium NV (Belgium) – 1639

29.  SGS FIMKO OY (Finland) – 0598

30.  SLG Pruf and Zertifizierungs (Germany) - 0494

31.  Slovenian Institute of Quality and Metrology – SIQ (Slovenia) – 1304

32.  SZUTEST Konformitatsbewertungsstelle (Germany) – 2975

33.  TUV NORD Polska (Poland) – NB 2274

34.  TÜV NORD CERT GmbH (Germany) – 0044

35.  TÜV Rheinland Italia SRL (Italy) – 1936

36.  TÜV Rheinland LGA (Germany) – 0197

37.  TÜV SÜD (Germany) – 0123

38. UDEM Adriatic d.o.o. (Croatia) – 2696

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR):

1.  3EC International (Slovakia) – 2265 

2.  BSI (Netherlands) – 2797

3.  DEKRA Certification (Germany) – 0124 

4.  DEKRA Certification (Netherlands) – 0344 

5.  GMED SAS (France) – 0459 

6.  MDC Medical Device Certification (Germany) – 0483

7.  National Standards Authority of Ireland (Ireland) - 0050

8.  QMD Services (Austria) – 2962

9.  TÜV Rheinland LGA Products (Germany) – 0197

10.  TÜV SÜD Product Service (Germany) – 0123 



1.  BSI Assurance (UK) – 0086

2.  DQS Polska (Poland) – 2282

3.  ECM (Germany) – 0481

4.  GMED SAS (France) – 0459

5.  Presafe (Denmark) – 0543

6.  SGS United Kingdom Limited (UK) – 0120


The 2023 "Win A Greater Health" Online Startup Pitch Contest by Taipei Entrepreneurial Hub

In collaboration with the Taiwan Digital Health Industry Development Association (TAIDHA), BE Health Ventures, and Taipei Medical University BioMed Accelerator, Taipei Entrepreneurial Hub is delighted to invite you to the "Win A Greater Health" Startup Pitch Contest. This competition presents a great opportunity to expand your business and establish a presence in Taipei, offering a platform for a soft-landing experience.


EVYD and A*STAR Open Joint Lab with a S$10 million Multi-Institutional, Cross-Border Collaboration to Advance Artificial Intelligence (AI) for Population and Digital Health

EVYD Technology and the Agency for Science, Technology and Research (A*STAR) have established a joint lab to advance artificial intelligence (AI) research for population health and digital health, to enhance healthcare solutions and drive positive impact for patients.



Fujifilm to reorganize its Medical Systems Group companies in Japan

FUJIFILM Corporation (President and CEO, Representative Director: Teiichi Goto) announced that it will reorganize its Medical Systems group companies in Japan to strengthen its Medical Systems business structure. Fujifilm will reorganize its group companies in Japan involved in the Medical Systems business based on their functional roles to further strengthen each function, including business strategy, R&D, and sales and maintenance services. The reorganization is scheduled to be completed in the summer of 2024.



Copper could help create clearer MRI images and improved diagnosis

Scientists have found a new use for copper in magnetic resonance imaging (MRI) contrast agent design, that could help to create better images which help doctors diagnose patients’ conditions more easily and safely. Researchers discovered a novel copper protein binding site, which does not occur in nature, that has real potential for use in MRI contrast agents used to improve the visibility of internal body structures in scans.


BrightHeart raises €2m for foetal heart defect detection with AI

BrightHeart, a Paris-based medical technology company developing artificial intelligence software focused on improving the detection of congenital heart defects in foetuses, has raised €2 million in seed financing from Sofinnova Partners, a European life sciences venture capital firm based in Paris, London, and Milan.

Process flow

Fund-Raising Starts with a Great Pitch Deck

What’s so different about MedTech?

Sometimes in certain pitching sessions, you may hear this: “our technology is the best of its class” “we can detect this condition 1000 times more quickly than our competitors” “we have made it smaller, cheaper”.

While they may be absolutely correct in their claims – usually there is some supporting evidence, we hope – we may feel “wow”, but somehow it did not capture something. It’s not about “capturing the imagination”, but more about capturing the point about touching the people and patient’s lives. What does that mean, “touching people and patient’s lives”?

When a Medical Device is deployed to patient, it is one part of the patient journey to either gain treatment, relief, or knowledge of one’s health condition. The medical device’s unique selling point (USP) must impact this journey in some positive way. Yes, the technology may be the best of its class, how does that impact the clinical workflow?

Yes, it is 1000 times faster in detection speed, how would that practically impact the speed the patient or doctor receives the result, because this detection may or may not be in the critical path.

Yes, it may be smaller or cheaper, but in the grand scheme of things, does it result in a significant impact in the overall treatment or diagnostic costs?

You may think this is just an issue of an inexperienced MedTech startup, in actual fact, the biggest “offenders” are the mid-sized MedTech companies trying to break through to the “Big League”. Focus on the patient and caregiver journey, clearly display the value of your device with respect to your profound knowledge of the clinical workflow in various markets. With the right dollars and SENSE, presents a great first step in gaining investment and funding.


Telea Medical's Q-Physio Lands in Singapore

Quantum Molecular Resonance (QMR), is an innovative and unique technology, developed and patented by Telea Electronic Engineering Srl QMR was born from a brilliant invention of Gianantonio Pozzato who already has a clear vision of the evolution of medicine and has been treating patients for more than 20 years.

QMR emits an alternating electrical signal containing a specific range of frequencies, from 4 to 16 MHz, that are the same as the molecular bonds in biological tissue.

The Q-PHYSIO Medical Device is designed for Physiotherapy, Rehabilitation and Sports Medicine. Due to the peculiar spectrum of multiple frequencies transferred simultaneously, and through its unique way of interaction at the cellular level, the injured tissue gets stimulated and induces regenerative processes.

The first 2 units of Q PHYSIO formally landed in Singapore and one of them is in Atlas Physio Clinic. If you are frustrated with slow recovery, or are in acute/chronic pain, please click here.

The holiday seasons are here, so get packing and visit some of these MedTech events!

Bio Asia-Taiwan Exhibition 2023

July 27-30, 2023

Taipei, Taiwan

Medlab Asia & Asia Health 2023

August 16-18, 2023

Bangkok, Thailand

India MedTech Expo 2023

August 17-19, 2023

Gandhinagar, India

MEDICAL Philippines 2023

August 23-25, 2023

Manila, Philippines

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