SMART news
KVALITO Malaysia Sdn Bhd is founded
KUALA LUMPUR, Malaysia October 28, 2020 KVALITO Consulting Group today announced the opening of a new office in Malaysia, which will help the company to accelerate growth in the APAC region. KVALITO Consulting Group is a strategic service partner and global Life Science network for regulated industries. ”For several years now, KVALITO has been ramping up its international service offering. With an increasing number of opportunities presented to us in Asia, especially Malaysia, China, Japan, Korea, and Southeast Asia, we are enthusiastic about establishing this new office and grow new partnerships in the region.” Selvi Nadarajan, Director, KVALITO APAC. This expansion consolidates the group’s international reach and signals KVALITO’s firm commitment to partnering with its clients in accordance with…
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SMART quality & compliance
How to conduct a Software Risk Assessment
First, the risk must be identified. It is always the same scheme; a hazard combined with a hazardous situation can lead to harm. All factors must be determined before the hazard occurs. Risks combine the severity of harm (S) and the probability of occurrence(O). A numerical score is assigned to assess the risk. Risk = probability of damage x severity of damage. A simple evaluation scale needs to be used and it must be equivalent for all products. See the table below as an example: Then the score is interpreted by this table: Then risk control measures must be defined…
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SMART quality & compliance
What is Software of an Unknown Provenance known as SOUP?
International standard IEC 62304 defines life cycle requirements for the development of medical software inside medical devices. This regulation is harmonized by the European Union and the United States and thereby serves as a standard by which to respect the regulations of both markets. A SOUP is a “software item that is already developed and generally available, and that has not been developed for the purpose of being incorporated into the medical device (also known as “off-the-shelf software”) or a software item previously developed for which adequate records of the development process are not available.” (Source: IEC 62304). The FDA defines SOUP as some…
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SMART news
Quality as a Driver in Organizations
KVALITO is a diverse company. Being a woman-owned business, we acknowledge equality and diversity in all our working practices. We support our entire team to achieve success within their projects and their career development. After all, without excellent consultants, KVALITO would not exist! We are continually looking towards the future to ensure that we support our clients in the most effective, innovative ways. We believe in staying on top of the latest developments and practices in the Life Science industry. KVALITO has embedded quality principles in its strategy since its founding. We believe that quality, being part of the whole…
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SMART news
Effective Communication
“Less is more”—Robert Browning “Andrea del Sarto” (1855) Communication truly is the engine of fruitful relationships. We often don’t think about the process of communicating while we are doing it, but paying closer attention to how you send and receive information can help you prevent misunderstandings, bolster your relationships and save time. We communicate to explain, inspire, ask, understand, and motivate. But do businesses sometimes fall short of effective communication? When teaching my toddler how to communicate, my primary goal is to break it down and to slow it down. Observing my child shows me how important tone, pace, eye…
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SMART news
How can we deal with conflict at work?
“Don’t fear conflict; embrace it – it’s part of your job.” —Clara Sayrol When a group of people comes together, conflict can arise and may become integrated into any part of a social and organizational setting. This is no different at work. The most common instigators of business conflicts have two root causes: poor communication and the inability to control one’s emotions. Conflict can start with a simple disagreement and often escalate into an argument that impedes the productivity of a team and decreases employee morale. Therefore, it is important to be able to recognize conflicts early on and address…
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SMART news
Meet Dimitrij Gvozdev
Meet Dimitrij Gvozdev We would like you to meet Dimitrij Gvozdev, who is passionate about working with KVALITO and the impact he makes in his role as Operations Manager, responsible for talent acquisition and management as well as key account management. What’s your professional background, and how did you become an Operations Manager? I completed my degree in Fitness economics (BA) in a dual study program before I started my journey with KVALITO. Fitness economics is a combination of medicine, fitness and business management. My study program combined academic studies with practical experience, which I liked a lot. After successfully…
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SMART news
Working from home is becoming the new normal for everyone
“Technology now allows people to connect anytime, anywhere, to anyone in the world, from almost any device. This is dramatically changing the way people work, facilitating 24/7 collaboration with colleagues who are dispersed across time zones, countries, and continents.” Michael Dell, Dell. Remote work is a trend that is gaining momentum fast, and it’s changing how the global workspace operates. In economies around the world, employees working from home or on the road are only part of the story. Consultants, contingent workers, contractors, freelancers, self-employed, and additional professionals make up the fastest-growing segment of the workforce today, and unconventional workspace…
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SMART quality & compliance
Vigilance from a Medical Device perspective
What is Vigilance? It is a system for the notification and evaluation of incidents and Field Safety Corrective Actions (FSCA) involving Medical Devices. (MEDDEV 2.12-1, rev.8) What steps shall the manufacturer follow to report an incident? Technical documentation needed for Conformity Assessment Before being launched on the EU market, Medical Devices must be approved by a conformity assessment procedure in order to get the CE mark. Conformity Assessment is mainly based on documents, one of these documents is the technical documentation. It is used to demonstrate compliance with regulatory requirements. Access to the US market also requires detailed documentation. Here…
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SMART quality & compliance
Medical Devices under the EU´s Changing Regulatory Framework
Some of the earliest known medical devices were being used in dental procedures between 7,500-9000 years ago in a Neolithic farming community from the Mehrgarh site (Indus Valley) in what is today, western Pakistan. Excavations of the site’s graveyard point to a 1,500-year-old farming community employing a long tradition of early dental techniques, as specifically observed in the molars of 9 adults from the area.[i] Flint-tipped bow drills used in early enamel drilling techniques consisted of assemblages of bone, shell, calcite, turquoise, lapis[ii], and other stones. Medical devices are products or equipment intended generally for medical use. [iii] Whilst there…
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