The concept actually aims at understanding the processes by defining their CPPs, and accordingly monitoring them in a timely manner preferably in-line or on-line and thus being more efficient in testing while at the same time reducing over-processing, enhancing consistency and minimizing rejects. With this framework — according to Hinz  — the FDA tries to motivate the pharmaceutical industry to improve the production process. Because of the tight regulatory requirements and the long development time for a new drug, the production technology is "frozen" at the time of conducting phase-2 clinical trials. PAT is a term used for describing a broader change in pharmaceutical manufacturing from static batch manufacturing to a more dynamic approach.
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- Whitepapers Guide Device Manufacturers Through FDA Testing, Cleaning Validation Regulations
- India extends med-tech registration deadline amidst regulations scramble
- Medical Device Industry
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- GxP Lifeline
- Operations Management Software
- Life Sciences
- Cobots: How will this new class of robotic technology fare in the modern workplace?
Whitepapers Guide Device Manufacturers Through FDA Testing, Cleaning Validation RegulationsVIDEO ON THE TOPIC: Bioprocessing Part 1: Fermentation
Diseases of the heart and circulatory system are the leading cause of death in Europe and a major cause of disability. Cardiovascular diseases can impact people of all ages.
However, the risk of cardiovascular disease, which includes heart failure, atrial fibrillation-related stroke, heart valve disease or coronary heart disease, increases with age. This regardless of gender, income or country. The edition is based on market size figures of and also includes macroeconomic and healthcare expenditure data for all 28 Member States, as well as for the European Free Trade Association EFTA members and Turkey.
Ami Ireland thought her hearing difficulties were just the remnants of a cold. Even in , cardiovascular diseases CVD remain the number 1 killer globally, accounting for almost 2 million deaths in the EU alone every year.
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There are more than , products, services and solutions currently made available by the medical technology industry. These range from bandages, blood tests and hearing aids to cancer screening tests, pacemakers and glucose monitors.
Our sector employs more than , people. Brexit is a critical topic for the medical technology industry which has developed highly complex ties between the United Kingdom UK and the rest of the EU. Medical technologies are often moved between different EU countries during their production lifecycle and their clinical use. MedTech Europe is tracking developments closely and has produced a position paper and other relevant documents to help medtech companies to navigate Brexit.
The medical technology industry is expected to find new ways to keep us healthy, and to do so in a responsible manner. MedTech Europe and its members are committed to a high level of ethical business practices and have put in place strict guidelines to advise medical technology manufacturers on how to collaborate ethically with healthcare professionals HCPs. Medical technologies have the potential to save and improve lives, to inform citizens on the state of their health and to guide healthcare delivery.
Medical technologies are tightly regulated in the European Union. Before a medical technology can be legally placed on the EU market, a manufacturer must comply with the requirements of all applicable EU legislation and affix a CE mark to their device. MedTech Europe is working with our members and the authorities to support companies in complying with the new legislation by the end of the transition periods — for MDs and for IVDs. The MedTech industry develops products that facilitate the delivery of health services in the community care setting and in people's homes.
These technologies save lives, are convenient for patients and make efficient use of healthcare resources. We acknowledge that preserving a healthy environment and building socially responsible value chains are essential in keeping human beings in good health.
Our industry needs to be at the forefront of addressing challenges related to sustainable healthcare. Information is power. Medical technology companies need to stay on top of the latest trends impacting their business. Informed decisions require up-to-date market intelligence from a trusted service. Medical technologies generate information and data that are critical for the prevention, diagnosis, treatment, monitoring and management of health and lifestyle.
More and more of this data is now digitised; it can be stored and accessed on electronic health records and personal devices, shared among patients and healthcare professionals, and aggregated and processed with data advanced analytics MedTech Europe works with policymakers and relevant stakeholders to realise the potential of data-driven healthcare.
Together we focus on legal and regulatory issues privacy, safety , technology cybersecurity, interoperability , the business case incentives, reimbursement , and emerging technologies precision medicine, artificial intelligence.
MedTech Europe engages with global agencies, decision-makers and stakeholders on key international issues facing medical technology companies. MedTech Europe is committed to working with others in the public and private sectors to find shared solutions to our common challenges. Vision loss can have a profound impact on those affected, resulting in lost independence and significantly limiting daily activities. Ageing increases the risk of eye diseases that can lead to visual impairment.
The MedTech industry develops products that reduce the burden of eye disease on individuals, families and the wider economy. These innovations add enormous value to European society. These infections cause significant morbidity and mortality, put pressure on health systems, and incur rising direct and indirect costs. Medical technologies can help to address these problems by preventing, detecting, monitoring and managing infections and resistance.
The MedTech industry develops products that reduce the burden of cardiovascular conditions on individuals, families and the wider economy. These innovations save lives and add enormous value to European society.
Orthopaedics is the medical specialty that focuses on injuries and diseases of the human body's musculoskeletal system. This complex system includes your bones, joints, ligaments, tendons, muscles, and nerves and allows you to move, work, and be active. The MedTech industry develops products that reduce the burden of musculoskeletal diseases on individuals, families and the wider economy.
These innovations improve quality of life and add enormous value to European society. This number increases significantly every year. If current trends continue, diabetes will be the number one health threat in the coming years. The European Diabetes Sector Group aims to reverse this trend by taking meaningful collective action to help avoid the diabetes pandemic where possible, and when diagnosis occurs to put people at the centre of care and give them back a full and fear-free life.
Less than one year to go before the new Medical Device Regulation comes into effect. Will the new system be ready on time? Find out more. Download here. MedTech Views - Your platform for dialogue about medical technologies Visit our blog. Latest updates. News MedTech Europe. Read more More news. Resource library Cardiovascular. Read more More resources. Read more. Sign up for our monthly newsletter. What will i receive? What will I receive?
MedTech Monthly, news from the medical technology industry delivered to your inbox: News and policy updates Latest events and industry opinion Blogposts and patient stories Close. MedTech Europe is the European trade association representing the medical technology industries, from diagnosis to cure.
Read more Members Board Staff. What we work on. Brexit Brexit Brexit is a critical topic for the medical technology industry which has developed highly complex ties between the United Kingdom UK and the rest of the EU.
Interactions with the Medical Community Interactions with the Medical Community The medical technology industry is expected to find new ways to keep us healthy, and to do so in a responsible manner. Access to Medical Technology Access to Medical Technology Medical technologies have the potential to save and improve lives, to inform citizens on the state of their health and to guide healthcare delivery.
Market Data Market Data Information is power. Digital Health Digital Health Medical technologies generate information and data that are critical for the prevention, diagnosis, treatment, monitoring and management of health and lifestyle. International International MedTech Europe engages with global agencies, decision-makers and stakeholders on key international issues facing medical technology companies.
Ophtalmology Ophtalmology Vision loss can have a profound impact on those affected, resulting in lost independence and significantly limiting daily activities. Cardiovascular Cardiovascular The MedTech industry develops products that reduce the burden of cardiovascular conditions on individuals, families and the wider economy. Orthopaedic Orthopaedic Orthopaedics is the medical specialty that focuses on injuries and diseases of the human body's musculoskeletal system. Diabetes Diabetes 1 in 11 adults around the world have diabetes.
We have recently upgraded our technology platform. Due to this change if you are seeing this message for the first time please make sure you reset your password using the Forgot your password Link. Innovations Other Manufacturing Technology. Collaborative robots have the potential to greatly benefit manufacturing processes - but just how important could they be in the future? Collaborative robots, or cobots, are a new class of robots that are bridging the gap between fully manual assemblies and fully automated manufacturing lines. Lightweight, flexible, easily programmable and safe to implement, cobots can meet some of the challenges associated with these processes in an efficient and effective way.
India extends med-tech registration deadline amidst regulations scramble
Good manufacturing practices GMP are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages ,  cosmetics ,  pharmaceutical products ,  dietary supplements,  and medical devices. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Good manufacturing practices, along with good agricultural practices , good laboratory practices and good clinical practices , are overseen by regulatory agencies in the United Kingdom, United States, Canada, Europe, China, India and other countries. Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance in order to ensure that a manufactured product is safe for human consumption or use.
Medical Device Industry
From pedometers to applications that manage cardiovascular risks and monitor diabetes, there has been a boom in e-health applications in recent years. Between and the estimated number increased from , to ,, and the market is expected to triple by Digitization is being used by pharmaceutical companies and in the field of life sciences to help find a balance between patient centricity and performance. These innovations make it possible to develop patient-centered medical products and services, and are bringing about a change in prevailing business models. These companies are shifting from the sale of simple products to the sale of complex health care solutions, such as a drug with a smart or connected medical device, supported by patient services. AKKA believes that technological developments will create new opportunities with regard to connected objects, websites providing day-to-day advice and mobile health care applications that will generate data from real-life situations.SEE VIDEO BY TOPIC: GMP 101 - Intro to Good Manufacturing Practice [WEBINAR]
The four evolutionary stages of manufacturing have brought us to Pharma 4. The first stage comprised the implementation of steam power to mechanization. The second involved mass production, and the introduction of the assembly line, powered by electricity. The third stage added computers and automation into the mix, and the fourth is the introduction of cyber-physical systems that enable the computerization of manufacturing Figure 1. This fourth stage, which is currently evolving before our own eyes, is the one that is becoming commonly referred to as Industry 4. It would even seem that Industry 4. The new buzzword for this that appears to be gaining some traction is Pharma 4.
W ant top-notch advanced process control? Get the basic regulatory control right, first. It is upon this foundation that effective advanced process control APC can be constructed. Maximizing return on investment ROI is always an important goal of plant management.
Process analytical technology
An effective quality system takes a total systems approach to satisfy safety, effectiveness, and performance requirements. Quality should be considered at all stages of production, starting at the earliest stages of product design. To ensure that finished devices will be safe and effective, current Good Manufacturing Practice cGMP requirements govern the facilities and controls used for the design, manufacture, packaging, labeling, storage, installation, and servicing of all medical devices. Vinny Sastri, President of Winovia LLC, who highlighted some of the key elements of effective production and process controls. We present some excerpts below.
Gain an understanding of the legal, operational and business issues relevant to the manufacturing industry. You should check our general business information for additional regulations and obligations relevant to your business. For further advice and assistance, contact your accountant, solicitor or business adviser. You may also wish to consult with an industry association or group for more information and advice on your industry. In additional to legislation, you should understand the manufacturing and processing standards to ensure your products, services and systems are safe and reliable. These standards include:. Manufacturers who package goods for distribution must understand specific packaging and labelling codes and standards that are specific to certain goods, including:.
Operations Management Software
The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. Atomic Energy United uranium. A special Government employee shall not use his Government employment to coerce, or give the appearance of coercing, a person to provide financial benefit to himself or another person, particularly one with whom he has family, business, or financial ties.
Two free whitepapers from Microtest Laboratories can help guide medical device manufacturers through the complex and changing landscape of Food and Drug Administration FDA regulations governing disinfection and cleaning validation requirements for reusable devices. Reusable medical devices come in all shapes and sizes from specula to colonoscopes.
Cobots: How will this new class of robotic technology fare in the modern workplace?
Biologics are bacterial and viral vaccines, antigens, antitoxins and analogous products, serums, plasmas and other blood derivatives for therapeutically protecting or treating humans and animals. Bulks are active drug substances used to manufacture dosage- form products, process medicated animal feeds or compound prescription medications.