Mediso Case Study: Consistency In A Changing Regulatory Environment Cognition has been a trusted resource for the largest and most prominent medical device and pharmaceutical companies for more than 20 years and pioneered Cognition Cockpit, an intuitive, web-based application empowering the Product Development Process (PDP). The company’s SaaS-based solutions – such as Compass – enable […]
Traceability: Navigating The Myriad Of Compliance Rules And Regulations Any newcomers to the medical devices manufacturing scene, could be forgiven for thinking that every part of their life has to be documented and evidence must be available. Well, that’s not far from reality, certainly in terms of all that relates to the development and production […]
Creating A Clear Market Pathway For Medical Device Manufacturers It’s hard to imagine an area that demands our utmost vigilance and attention to detail more than medical device manufacturing. One production error can potentially mean the difference between life and death. Today, according to the World Health Organisation (WHO), there are an estimated 2 million […]
Breaking The Regulatory Burden At first glance, the development of breakthrough innovations in the medical devices sector can seem enticing for a tech-savvy startup. A dynamic market place, the sector is set to grow at a CAGR of 6.1% from 2021 and reach $603.5 billion in 2023. Often commanding high unit prices, medical devices enjoy […]
Risk & Reward: Taking The Guesswork Out Of Compliance & Safety For Medical Devices The world-famous and often quoted maxim: ‘the one constant is change’ certainly holds true for the medical devices sector. That doesn’t stop at the fast pace of innovation, but starts at the minefield of compliance and regulation that is rightly imposed […]
Helping Medical Device Businesses To Balance Fast Development & Meet Regulatory Frameworks When does product development become a matter of life and death? There are high stakes riding on the development of medical devices and manufacturers. Everyone from startups to global players often only get a limited opportunity to jump from prototype to a wider […]
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