Latest news with #MDR
Yahoo
a day ago
- Business
- Yahoo
Changing regulations impact medical device market entry strategies
The medical devices industry is always undergoing significant regulatory changes. In the EU and UK there have been new frameworks introduced recently, and as a result the medical device industry is consistently navigating a complex and evolving regulatory framework that has implications on medical device company market strategies. The EU Medical Devices Regulation (MDR) came into effect on 26 May 2021. The regulation introduced several changes to medical device regulation in Europe, including stronger market surveillance, establishing explicit responsibilities for manufacturers, improved traceability, a central database for comprehensive information on medical products, and high-risk device assessment. Additionally, in July 2025, the Competent Authorities for Medical Devices and the Head of Medicines Agency issued a statement advocating for significant medical device regulation reforms in the EU. Specifically, they are advocating for improved coordination, governance, and centralisation of regulatory activities in the EU. Similarly, in the UK, new Post-Market Surveillance regulations have taken effect in June 2025. The new regulations require device manufacturers to track the safety and performance of products to help identify safety issues early. The regulations will ensure manufacturers have a system in place to monitor devices once in use, collect safety data, report serious incidents, and take action quickly when any issues arise. These changes and expansions mean that manufacturers need to navigate complex landscapes of regulations that govern various aspects of medical device production. The need to comply with these regulations can lead to increased operational costs and may limit the ability to rapidly introduce new products. Changes and expansions in regulations can significantly impact market entry strategies. The evolving landscape often results in longer timelines to get necessary approvals, ultimately hindering a company's ability to enter the market with new products quickly. This can divert resources from other critical areas such as research and development or marketing, potentially impacting overall competitiveness. Due to the complexity of regulatory requirements, companies may consider forming strategic partnerships with local companies that have established regulatory pathways. This can facilitate smoother market entry and compliance with local laws. Companies should establish robust compliance programmes to monitor adherence to both domestic and international regulations. Companies that have proactively adapted their product development processes to comply with new regulations tend to perform better. For example, companies that invested in understanding the MDR and preemptively adjusted their clinical trial protocol to align with the requirements likely gained a competitive edge. The implications of medical device regulations on market entry strategies are profound. Companies should be prepared to navigate an increasingly complex regulatory environment. Successful market entry strategies involve a combination of compliance, strategic partnerships, technological innovation, and localised market research. "Changing regulations impact medical device market entry strategies" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Hans India
2 days ago
- Health
- Hans India
20-day-old preterm baby with rare gut disorder treated successfully
Bengaluru: Aninfant girl, when she was brought to Sakra World Hospital, Bengaluru, was only 20 days old and in critical stage with difficulty in breathing and unable to take her feeds. She weighed 1.76 kg with signs of a serious infection (sepsis) with a swollen belly. Her condition was urgently evaluated and treated under the expert care of Dr Anilkumar PL., Senior Consultant and Head of Paediatric Surgery, Sakra World Hospital, Bengaluru. The baby girl was born prematurely at just 33 weeks through an emergency C-section at another hospital due to multiple complications, including breech position (baby not head-down), early water break (PPROM), and signs of distress. On her second day, she started vomiting greenish fluid, a sign of a serious problem. Tests showed a rare and complex condition called Type 3b jejunal atresia, where part of her small intestine was blocked and had an unusual 'Christmas tree' blood supply. During surgery, doctors also found that her intestines were not in the normal position, a condition known as malrotation. Her condition was critical from the start, needing a ventilator due to trouble breathing and had surgery on her 2nd day. She was cared for in the NICU after surgery but by day 19, her belly became swollen again and she showed signs of infection (sepsis). Dr. Anil shared, 'The biggest risk was prematurity. During evaluation we found there were internal scars (adhesions) and unusual anatomy from the first surgery, severe infection (sepsis) caused by drug-resistant E. coli in the belly, stuck bowel loops, and a dead (gangrenous) part of the intestine. The damaged part was removed, followed by a bowel lengthening procedure called Heineke-Mikulicz, and reconnected the healthy bowel, and placed a feeding tube through the stomach.' Colistin, a strong antibiotic, was started to fight the MDR infection. 'It was also difficult to get good IV access for fluids and medications. The bowel lengthening procedure (Heineke–Mikulicz) was very complex because the baby's intestine was very thin and fragile. The 'Christmas tree' shape of the mesentery (the tissue that carries blood to the bowel) made it riskier, as blood supply could be affected. Still, this procedure was necessary to increase the surface area for absorbing nutrients, since the baby had very little intestine left', he added. The outcome of the surgery was, only 30 cm of healthy small intestine remained, and the baby was diagnosed with short bowel syndrome. With careful monitoring and support from pediatric gastroenterologists, her feeding gradually improved. By 45 weeks, she was on full oral feeds. She also received blood transfusions for anemia, and her vital organs and infection markers were closely tracked. Under strict care and hygiene, she recovered well and was discharged in June 2025, weighing 2.06 kg and feeding successfully. Jejunal atresia and malrotation are issues that usually can't be prevented. Premature babies, especially those born before 34 weeks, have weak intestines and are more at risk for feeding problems, infections, and conditions like NEC. In the infant girl case, she also had an infection from multi drug resistance (MDR). If a large part of the intestine is damaged, it may need to be removed, leading to short bowel syndrome, where the body can't absorb enough nutrients. The infant girl's parents shared, 'We had completely lost hope, but Dr. Anil saved our child. We are extremely happy to take our daughter back to health because of Sakra's constant support and care.'
Business Wire
6 days ago
- Business
- Business Wire
Compliance Group Inc. and Loftware Announce Strategic Partnership to Drive Digital Labeling Transformation in Life Sciences
CHICAGO--(BUSINESS WIRE)--Compliance Group Inc., a premier validation, regulatory consulting firm serving the Life sciences industry, is thrilled to announce its strategic partnership with Loftware, a global leader in product identification and supply chain transparency. Purpose-Driven Partnership for a Compliant, Scalable Future Loftware's powerful, cloud-enabled labeling technology with CG's deep labeling expertise and proven Computer Software Assurance (CSA) aligned validation strategies, the partnership delivers: World class labeling consulting & End-to-end support Insights into inefficiencies and compliance gaps in legacy systems Expert guidance on system migration & architecture alignment FDA, MDR, Global ISO compliant validation (IQ, OQ, PQ) Integration with enterprise systems (SAP, Oracle, Veeva, etc.) Real-World Impact: Leading Global MedTech Transformation A global leader in medical devices selected CG to lead the replacement of their Global Labeling System (GLS). Our team conducted: Thorough assessment of legacy system Vendor selection & Loftware readiness planning Define requirements with expert consulting Validation aligned with CSA, FDA, & Global ISO standards Full implementation with audit readiness Executive Perspectives "Our partnership with Loftware reinforces our commitment to helping clients build innovative, scalable, and compliant labeling systems. With our AI powered design validation approach, we enable life sciences companies to move faster while staying inspection ready.' added Sarat Bhamidipati, CEO, Compliance Group Inc. "We're excited to partner with Compliance Group to help life sciences organizations modernize their labeling environments while meeting the industry's rigorous regulatory requirements. By combining our cloud-based labeling solutions with Compliance Group's deep validation and regulatory expertise, we're enabling companies to accelerate digital transformation, reduce risk, and ensure long-term compliance," added Carter Johnson, Vice President, Global Alliance Sales at Loftware. About Compliance Group Inc. CG is a leading consulting & validation partner for the Life sciences industry. Our experts bring decades of regulatory experience & specialize in validation, label consulting, and digital transformation. With a vendor-neutral, AI-driven approach, we use people, platforms, and processes to build a compliant, scalable quality system. Learn more at About Loftware Loftware is the global leader in product identification, artwork management, and connected packaging. Our cloud-based solutions power real-time collaboration, ensure compliance, improve authenticity, and deliver supply chain visibility from product development to consumer engagement. We provide scalable, data-driven labeling and packaging technologies that help companies boost speed to market, enhance efficiency, and connect physical products to digital experiences. Trusted by global brands and backed by over 40 years of innovation, Loftware supports customers across industries with offices in the US, UK, Slovenia, China, and Singapore. Learn more at
Techday NZ
16-07-2025
- Business
- Techday NZ
Bitdefender named sole Visionary in 2025 Gartner EPP report
Bitdefender has been named the only Visionary in the 2025 Gartner Magic Quadrant for Endpoint Protection Platforms, marking its third consecutive year in this position. According to Gartner, the Magic Quadrant evaluates 15 vendors on their completeness of vision and ability to execute, considering criteria such as market understanding, product and service capabilities, business model, innovation, geographic presence, and customer experience. Bitdefender's recognition follows the introduction of GravityZone Proactive Hardening and Attack Surface Reduction (PHASR), described as an endpoint security solution offering individually tailored hardening for employees based on their behaviour patterns, use of tools, and application activity. Daniel Daraban, Vice President of Products, Bitdefender Business Solutions Group, commented on the recognition: "To us, being named the only Visionary in this year's Magic Quadrant signals that the industry is ready for a more intelligent, proactive approach to security. We believe this recognition reflects our long-standing commitment to building the future of cybersecurity – where security is tailored, risk is managed in real-time, and compliance is built in. With our GravityZone XDR platform and MDR services, we empower defenders to work more effectively and efficiently, because that's what really matters. We're proud to lead where others are only beginning to explore." The Gartner evaluation assessed each vendor's strategy across marketing, sales, and offerings, as well as execution factors such as sales performance, pricing, market responsiveness, and client feedback. Platform development Bitdefender's GravityZone platform brings together endpoint protection (EPP), endpoint detection and response (EDR), extended detection and response (XDR), and cloud-native security into a unified package. The platform is designed to provide risk analytics and compliance alongside advanced security context for incidents, integrating directly with Bitdefender Managed Detection and Response (MDR) services. The company has continued to build on this platform, with enhancements such as GravityZone Compliance Manager, GravityZone Extended Attack Surface Management (EASM), and the newly introduced GravityZone PHASR. Recent achievements Bitdefender reported several notable results in independent industry evaluations during the last year. It was named a 2025 Gartner Peer Insights Customers' Choice for Endpoint Protection Platforms, receiving a 4.8 out of 5 aggregate rating from 214 GravityZone customer reviews. Only four other vendors shared this distinction. In the AV-Comparatives Business Security Test, Bitdefender was one of 17 participants and the only vendor to achieve a 100% protection rate, blocking all 483 test cases. The GravityZone platform also scored 98.8% in protecting systems from malware infections before, during, or after execution of malicious files. In the MITRE ATT&CK evaluations, GravityZone was noted for its alert accuracy and minimal false positives, generating an average of only three alerts needed to identify and report incidents to the security operations centre. This is compared to the median of 209 alerts across other solutions tested. Bitdefender was also named a Strong Performer in the Forrester Wave: Extended Detection and Response for the second quarter of 2024. The evaluation covered 11 vendors and 22 specific criteria, including analyst experience, artificial intelligence and machine learning, endpoint protection, and product security. Customer perspective User testimonials reflected positive feedback. In a Gartner Peer Insights review, an IT Director from a services sector enterprise wrote: "Our overall experience with GravityZone has been excellent. It does a great job of protecting our endpoints while not causing any performance or stability issues once properly configured. I would highly recommend GravityZone to fellow IT Directors and System Engineers." Bitdefender executives suggested the continued recognition is a sign of the company's direction in developing solutions that move beyond reactive security to methods that adapt to organisational risks dynamically. The Gartner Magic Quadrant and Peer Insights are based on analyst research and customer input, respectively, and aim to provide a structured analysis across the market's key players.
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Business Standard
15-07-2025
- Business
- Business Standard
PhonePe ropes in Meta's Shivnath Thukral as V-P for public policy
Digital payments company PhonePe has appointed Shivnath Thukral, former public policy head at Meta India, as its new vice-president for public policy and government affairs. Thukral's seven-year tenure at Meta came to an end in June. "Shivnath will be responsible for leading PhonePe's external engagement and discussions with policymakers and regulators," the company said in a statement, adding that he would work closely with the company's founders, Sameer Nigam and Rahul Chari. Nigam said that they were delighted to have Shivnath join the PhonePe team, adding that he came with rich experience and a deep understanding of public policy, regulatory frameworks, and strategic advocacy. Appointment ahead of IPO plans Thukral's appointment comes at a time when the Walmart-owned fintech prepares to launch its initial public offering (IPO), which is expected to value the company at around $15 billion. PhonePe is aiming to file its draft red herring prospectus (DRHP)—a preliminary document required by Indian regulators—by early August. However, the timeline may still change, as discussions are ongoing and the plan remains flexible. To handle the IPO process, PhonePe has brought in major investment banks including Kotak Mahindra Capital, JPMorgan Chase, Citigroup, and Morgan Stanley. PhonePe's market leadership in UPI PhonePe holds the top position in India's digital payments space, with nearly 48 per cent market share in the Unified Payments Interface (UPI), the real-time mobile payment system operated by the National Payments Corporation of India. PhonePe was initially registered in Singapore but moved its legal base to India in 2022. This shift is widely seen as a step taken in preparation for its planned public listing in the country. In June, the company appointed Zarin Daruwala to its board. Daruwala, who served as CEO of Standard Chartered Bank India, had previously held key leadership positions at ICICI Bank, where she led the wholesale banking business. Thukral's appointment comes at a significant moment, as the debate around the Merchant Discount Rate (MDR) has reignited. The Payments Council of India (PCI) recently wrote to Prime Minister Narendra Modi, urging the introduction of MDR on both Unified Payments Interface (UPI) transactions and Rupay debit cards.
