Global medtech News

The search for the "ideal professional" has become increasingly challenging. With the advancement of technology, digital transformation and the constant evolution of work models, the market requires complex skills and a constant ability to adapt. But there is an important question that many organisations still ignore: who is training these professionals? The answer should often be: we, as companies, leaders and society. The Barrier of Experience One of the biggest paradoxes of the current labour market is to require previous experience from those who are just trying to conquer their first opportunity. This requirement excludes young people, people in career transition, mothers who return to the market after motherhood, and several other profiles that have a lot to contribute - but need a starting point. Denying this gateway means limiting access to professional dignity and no longer seeing the potential of individuals who, with adequate support, can become valuable assets wit...

Starting in a new job always involves anxiety, expectations and the natural learning curve. But when this experience happens on another continent - with another work culture - the impact can be even greater. If you come from the Brazilian market and are joining the European industry, it is important to understand that the onboarding process (integration and monitoring of the new employee) works differently. Below, we highlight the main points of contrast: 1. Structure and formalisation of onboarding Brazil: Onboarding can vary greatly between companies. In many organisations, there is an initial focus on administrative aspects (documents, access to systems) and a presentation of the culture and area. However, there is not always a structured continuous monitoring program. Europe: In most European countries, especially in multinational companies, onboarding is highly structured and follows a clear integration plan, which can last from 30 to 90 days or more. The process usually includes:...

The transition from the hospital environment to the universe of medical writing may seem challenging, but it is totally possible - and very strategic! The pharmacist already carries a valuable technical background that can be applied directly in the scientific and regulatory writing, especially for his practical experience with medicines, protocols and clinical data. Steps to become a Medical Writer: 1. Understand what a Medical Writer does Medical writers transform technical information from the health area into clear, objective and well-structured content. This can include everything from scientific articles to regulatory documents and educational materials. 2. Take advantage of your clinical background You already have in-depth knowledge about medicines, pharmacology, clinical protocols and even pharmacovigilance. All this is gold in medical writing. 3. Invest in specific training Search for courses on: •Scientific writing •Regulatory writing •Pharmacovigilance •Clinical research (G...

If you dream of migrating to areas such as Regulatory Affairs, Medical Devices or Pharmacovigilance, but feel that the budget is short, know that it is possible to specialise with intelligence, focus and few resources. I have been walking this path myself - and I can say: it works! Here is a practical guide for those who want to learn consistently and spending little: 1. Start with a clear goal and a learning trail Choose an area (e.g. Regulatory Affairs, QA, Clinical Trials) and set up a study trail with the main themes. You can organise this in a planner, notebook, spreadsheet or app like Notion, Trello or even Google Keep. The important thing is to have a clear vision of what to study and where to start. 2. Use accessible (or free) platforms Here are some great options: • Coursera, edX: free courses from renowned universities (with paid certificate option). •FutureLearn: courses on medical devices, regulation and public health. •OpenWHO: great content on pharmacovigilance, healt...

If you write frequently - whether technical, scientific, creative or professional texts - it is likely that you have already looked for ways to improve clarity, fluidity and impact. And that's exactly what Gary Provost delivers in 100 Ways to Improve Your Writing. What makes this book special? Unlike theoretical manuals, this book is objective, practical and straight to the point. With short chapters, it offers applicable tips from the first paragraph. No generic rules: each of the "100 ways" is explained with examples and context. Some of the topics covered include: •How to make your writing clearer and more engaging •The importance of rhythm and variation of sentences •Tips for reviewing and cutting excesses •How to keep the reader interested until the end •The difference between writing to sound intelligent and writing to be understood One of the most striking excerpts: "This sentence has five words. Here are five more words. Five-word sentences are fine. But seve...

If you are a pharmacist or health professional and want to migrate to the area of Medical Writing, but don't know where to start, this post is for you! We have prepared a 4-week study plan to guide you through the fundamentals of scientific writing and present the universe of Medical Writing. Let’s start with me? Week 1 to 4 - Introduction to Medical Writing and Scientific Language Objective : Understand what Medical Writing is, its different types and the basic principles of clear, objective and evidence-based scientific writing. ⸻ What is Medical Writing? Medical Writing is the production of technical and scientific content on health, medicines, clinical studies and health education. The performance can vary from the creation of regulatory documents to educational materials for patients. Main Types of Medical Writing: • Regulatory writing - documentation for agencies such as ANVISA, FDA, EMA; • Scientific publications - scientific articles, reviews, clinical studies; • Medical ...

Inventory control is one of the most sensitive and strategic gears in the pharmaceutical area, whether in the hospital or industrial environment. Effective management avoids waste, ensures patient safety and maintains regulatory compliance. Although the contexts are different, both require organisation, continuous monitoring and data-driven decisions. Next, see specific strategies for each scenario: ⸻ In hospital pharmacy: focus on agility and patient safety In the hospital, the stock is directly linked to care. Any failure can compromise the treatment. How to optimise: 1.ABC x Criticality Rating •Organise medications by volume of use (ABC) and clinical criticality. This helps to prioritise the replacement of essential inputs. 2. Replacement point and minimum stock •Establish safe inventory levels, based on replacement time, average demand and disruption risks. 3.Regular inventories •Perform periodic counts (cyclical and general) to identify losses, malfunctions or deviations. 4.In...

Europe has one of the most demanding markets when it comes to quality, safety and regulatory compliance. Below, you will find free courses and resources in English - many of them directly focussing on the European context. ⸻ 1. EU-GMP Guidelines - Introduction to Good Manufacturing Practises Essential for everyone who wants to work with production, QA or validation in the European pharmaceutical industry. •Course: Introduction to EU-GMP Guidelines •Platform: Coursera / Pharma Lessons / ECA Academy (some free or trial versions) • Tip: Read the EMA (European Medicines Agency) guides available for free on the official website. ⸻ 2. Process Validation and Cleaning Validation (Process Validation & Cleaning Validation) For those who want to work with validation of production processes or cleaning systems. •Course: GMP Compliance - Cleaning Validation •Platform: ECA Academy (some free webinars) •Complementary: ISPE Guidance Documents (require registration, but there are open materials...

The position of Quality Assurance Technician is one of the most affordable - and strategic - gateways to the medical device industry. But where to start? 1. Essential training Although many entry-level vacancies accept different backgrounds, these are the most valued training: •Technical or Higher Education in the areas of: • Biomedical engineering •Pharmacy •Biotechnology •Chemistry or Biochemistry • Production or Industrial Engineering •Health or Biological Sciences Knowledge in basic statistics, microbiology, and process validation are also important differentials. ⸻ 2. Desired skills and technical knowledge •ISO 13485 - Quality Management System for medical devices •Good Manufacturing Practises (GMP) •Control of documents and records •Internal audits (ISO or FDA) •Quality tools - COVER, 5 Whys, Pareto, Fishbone •MS Office, Excel and ERP systems (e.g. SAP) ⸻ 3. How to specialise online (and for free) Free and affordable courses: •Coursera - "Medical Device Regulation in Europe...

Ireland is recognised as one of the leading global centres of the medical device industry, housing more than 450 companies in the sector and employing about 50,000 professionals, which makes it the largest employer of MedTech professionals per capita in Europe. In addition to their industrial strength, several companies stand out for offering exceptional work environments, being recognised by rankings such as Great Place to Work and LinkedIn Top Companies. 🏆 Featured Companies in Ireland 1. STRYKER With units in Cork and Limerick, Stryker is one of the largest employers in the industry, with approximately 4,500 employees in Ireland. The company is recognised for its culture of innovation and excellence, offering opportunities for professional growth and continuous development. 2. BOSTON SCIENTIFIC  Present in Galway, Clonmel and Cork, Boston Scientific employs about 6,400 people in Ireland, being the largest employer in the sector in the country. The company is known for its commi...

The classification of medical devices is an essential step in the regulatory process. It determines the level of risk associated with the product and defines the technical and clinical requirements necessary for its approval and marketing. Below, I explain the main risk classes used by regulatory agencies. 1. Classification according to ANVISA (Brazil) ANVISA classifies medical devices into four risk classes, based on the criteria of Regulation RDC No. 751/2022: •Class I - Low Risk: Simple devices, for non-invasive use, with transient contact with the body. Examples: dressings, digital thermometers. • Class II - Medium Risk: Devices a little more complex, but still considered of moderate risk. Examples: syringes, surgical gloves, dental instruments. •Class III - High Risk: Invasive, implantable or drug-releasing products. Examples: orthopaedic prostheses, vital signs monitors. • Class IV - Very High Risk: Critical devices, usually implantable or that support life. Examples: pa...

The Health Products Regulatory Authority ( HPRA ) is the competent national authority in Ireland. It is responsible for ensuring that medical devices in the Irish market comply with European Union legislation. HPRA does not issue CE marking certifications, but: • Supervises manufacturers based in Ireland; • Performs inspections; • And it tracks incidents related to device security. HPRA official website: Https://www.hpra.ie ⸻ Applicable Legislation The legislation governing medical devices in Ireland is based on European regulations: • Regulation (EU) 2017/745 (MDR): For medical devices in general • Regulation (EU) 2017/746 (IVDR): For medical devices for in vitro diagnosis These regulations replaced the old European directives (MDD/IVDD) and raised the level of demand in terms of safety, clinical evidence and traceability. ⸻ Quick Example: Who Needs Approval? • Company A has developed a wearable sensor that monitors heart rate - needs CE marking and technical submission. • Company B...

By Viviane Santos – Pharmacist & MSc Candidate in Medical Technology – Regulatory Affairs If you’re curious about Regulatory Affairs (RA) but don’t have industry experience, this guide is for you. Below, I share a practical roadmap and a free 6-week online study plan to help you take your first steps into this exciting and strategic field. ⸻ Step-by-Step: Starting a Career in Regulatory Affairs 1. Understand what Regulatory Affairs is RA professionals ensure that medical products (drugs, devices, cosmetics, etc.) meet all regulatory requirements to be marketed safely and legally. 2. Learn the key regulations Start with the basics: • EU MDR 2017/745 (Medical Devices – Europe) • FDA 21 CFR Part 820 (Quality Systems – USA) • ISO 13485 (QMS for Medical Devices) • ANVISA RDCs (Brazil) 3. Build technical English skills Most regulatory documentation and communication is in English. Use glossaries from the FDA or EMA to get familiar. 4. Explore real...