Digitalization For The
MEDICAL DEVICE & PHARMACEUTICAL INDUSTRY
Digital transformation in the medical device and pharmaceutical industries is accelerating amidst the backdrop of COVID-19. Companies are looking to technology to help them drive business continuity, maximize revenue growth, and improve patient outcomes at every step along the supply chain.
Our team of subject matter experts can assist you with meeting industry and governmental requirements, as well as providing strategic direction on taking advantage of digital technologies.
Working with our partner Siemens Digital Industries Software we offer solutions for leading companies in the medical device and pharmaceutical industries that recognize the need for a lifecycle management platform to answer product development challenges. Their proven, flexible solutions help speed up innovation in pharmaceutical and medical device development, ensure quality, reduce costs and maintain adherence to ever-changing global regulations.
It all begins with an idea or requirement. Maybe you are looking for a solution to give you peace of mind when dealing with supply chain or governmental audits. Maybe you want to find a smart & efficient way to harmonize your engineering and manufacturing processes or tighten up your supplier collaboration. Maybe you want to grow from distribution to manufacturer or grow your product portfolio. Whatever it is, our team of subject matter experts can support you from addressing compliance and regulatory requirements to guiding you through a software evaluation of pre-configured, rapid deployment solutions from Siemens Digital Industries Software.
Quality Assurance & Regulatory Affairs
Our QA/RA management consulting team provides a broad range of advisory services, support, and technical talent to help your organization achieve successful business and compliance outcomes.
Achieve and maintain compliance
Advisory support for your QA/RA unit or leadership
Implement and improve your QMS
Train your team
Develop world-class compliance systems and strategies
LMtec Group’s QA/RA management consultants have extensive experience working with and for companies in the life sciences industry. This allows us to fulfill a variety of roles by providing expertise related to quality and regulatory system design, practices, and improvements.
Focusing on more than just compliance, our aim is to help you ensure your QA/RA functions provide quality and regulatory excellence while positively contributing to the overall success of your business.
Lifecycle Collaboration
Consolidate and connect the output of your existing systems for faster execution and improved productivity. Digital lifecycle management solutions for the medical device and pharmaceutical industries allow you to do more with your technical information in an integrated, highly accessible, yet secure environment. Whether it’s managing change, executing work processes, improving quality, or connecting external suppliers and customers, it all starts with a holistic approach to centralizing technical information and ensuring it remains up-to-date. This results in better, more informed decisions across the entire enterprise and safer, more effective products for the end-user.
Design Excellence
Innovation that enables smart, interconnected devices, along with the coupling of therapy and diagnostics, promises more effective disease treatments. The key to success, enabled by our Design Excellence Solutions, is a multidisciplinary development of systems that integrate hardware, electronics, software, and formulated components. Tie off risks and requirements and discover issues earlier by leveraging digital simulation to predict performance and optimize devices. Manage the complexity of change at every phase with agility, efficiency, speed and accuracy.
Manage Complexity & Change While Reducing Risk of Non-Compliance
The process of dealing with quality issues such as Corrective and Preventive Actions (CAPA) and product complaints is a significant source of regulatory risk for medical device & pharmaceutical manufacturers today.
Trends that are impacting your industry…
Increasingly Stringent Regulations
New legislation places tighter requirements on quality, traceability and security throughout the supply chain.
Unpredictable Demand for Products & Services
COVID-19 has created unprecedented uncertainty in the industry, with some organizations seeing unprecedented demand while others greatly reducing sales forecasts.
Growing Risk & Price Pressures
Revenue risk often results from patent expirations with leading companies forced to compete against generics. Meanwhile, the industry as a whole faces price pressures from payors and governments around the globe trying to cut healthcare costs.
Increased Competition & New Market Entrants
New and non-traditional market entrants are on the rise globally and accelerating new product introductions and time to market for the industry as a whole.
Helping People Live Healthier Lives
Inefficiencies are common in today’s world of research and medicine, compounded with the need for more precise, sustainable patient care. Shifting the focus to deliver superior, patient-centric, outcome-driven experiences and creating the processes to support them transforms how therapies are discovered, developed, produced, commercialized and used.
Acceleration of Digital Technologies
Technologies like AI, IoT and machine learning will bring innovative therapies, smarter, connected patient products faster with lower costs.