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LIFE SCIENCES LAW – Ralph Schäfer – Lawyer
Lawyer for MedTech and Health Care
Your partner for legal issues in the life sciences industry
MedTech and Health Care – Safely Shaping Innovation in the Regulated Healthcare Market
The MedTech and healthcare industry is among the most innovative and, at the same time, most heavily regulated sectors of the healthcare sector. Medical devices, digital health applications, software solutions, networked systems, and new care models are fundamentally changing diagnostics, therapy, and care. Simultaneously, regulatory requirements are constantly increasing – both at the European and national levels.
Companies in the MedTech and healthcare sectors operate within a complex environment of technological innovation, patient safety, regulatory responsibility, and competitive pressure. Decisions regarding development, classification, market entry, and distribution have immediate legal and economic consequences. Errors or delays can jeopardize market access, devalue investments, or trigger liability risks.
Life Sciences Law supports companies, startups, manufacturers, distributors, clinics, and digital healthcare providers in addressing these challenges in a structured and legally compliant manner. The consulting services encourage clear decisions throughout the entire product lifecycle – from the initial idea and market launch to ongoing market surveillance.
Regulatory complexity as a strategic factor
With the Medical Device Regulation (MDR), the In Vitro Diagnostic Regulation (IVDR), and the national implementing legislation, the requirements for medical devices and digital solutions have become significantly stricter. Clinical evaluations, conformity assessment procedures, quality management systems, vigilance, and post-market surveillance are no longer isolated obligations, but rather key strategic factors.
In addition, new demands are being placed on software, AI-supported systems, digital health applications, and data-driven care models. Questions of product demarcation, intended use, liability, and responsibilities along the supply chain are becoming increasingly important. Topics such as IT security, data integrity, and interfaces between technology and healthcare are also moving more into focus.
Health Care as a networked system
Today, healthcare is far more than traditional care provided by hospitals and doctors' offices. Pharmacies, digital platforms, healthcare networks, telemedicine, e-prescription infrastructure, and new cooperation models are shaping the market. Companies must simultaneously keep an eye on regulatory requirements, professional obligations, data protection, reimbursement systems, and liability issues.
New legal questions arise, particularly at the interfaces between MedTech, digital health, and healthcare. These concern not only the approval of products, but also their application, integration into existing systems, and interaction with regulatory authorities.
Practical support for complex decisions
Life Sciences Law stands for consulting that does not consider regulatory requirements in isolation, but rather places them within the economic and operational context of companies. The goal is to develop solutions that are legally sound and, at the same time, practical to implement in everyday business.
Whether a start-up, a growing MedTech company, or an established healthcare provider – a structured, forward-looking approach is crucial. It creates planning certainty, reduces risks, and enables innovation without overstepping regulatory boundaries.
The focus is on a collaborative partnership based on mutual respect. Complex regulatory issues are clearly structured, presented in an understandable way, and strategically contextualized. This leads to decisions that don't just ensure compliance, but rather secure long-term success in the MedTech and healthcare markets.
Submit your inquiry now
We will gladly advise you comprehensively and personally on your request.
Submit your inquiry now
We will gladly advise you comprehensively and personally on your request.
Why Life Sciences Law?
Life Sciences Law Ralph Schäfer combines specialized legal advice with genuine leadership experience from the life sciences industry. Admitted to the bar for 27 years, he has held various roles as in-house and external legal counsel and business manager in international companies, including General Counsel and board member of a publicly listed biotech company, as well as in associations.
These include, among others:
- 10+ years as General Counsel and Corporate Counsel international, publicly listed medical technology, biotech and pharmaceutical company
- Long-standing responsibility in senior positions, long-time member of the management team, and as a board member of a listed biotech company, with a focus on law, compliance, strategy and regulation
- Extensive experience as a compliance officer of a publicly listed biotech company
- Extensive experience at the interface of pharmaceuticals, biotech, medtech and health care
- Solution finder, strategy partner and legal guide for executive and supervisory boards
This combination of legal expertise and operational management practice enables the firm to provide advice that is legally precise, economically viable, and practically implementable. The firm stands for personal, pragmatic, and ethically oriented support in the highly regulated life sciences environment.
The MedTech & Health Care sector encompasses the development, manufacturing, and application of medical devices, digital health applications, software solutions, diagnostic systems, and new healthcare delivery models. It combines technological innovation with medical care.
This includes medical technology manufacturers, software and digital health companies, start-ups, distributors, clinics, pharmacies, health platforms and other players along the supply chain.
Medical devices and digital applications have a direct impact on patient care and safety. Regulatory requirements ensure that products can be used safely, effectively, and transparently.
The Medical Device Regulation defines the requirements for classification, conformity assessment, clinical evaluation, CE marking, market surveillance and responsibilities of all economic operators.
Digital applications raise questions about product demarcation, liability, IT security, data integrity, market surveillance, and responsibilities between manufacturers, operators, and users.
Even in the early development and concept phases, structured support helps to define the regulatory path, avoid later corrections and secure market entry strategies.
Hospitals, medical practices, and pharmacies are key users of medical products and digital systems. Their integration brings with it additional regulatory, professional, and liability requirements.
Particularly relevant are software as a medical device, AI-supported systems, telemedicine, e-prescription infrastructures, digital networking, IT security and new cooperation models in healthcare.
Once placed on the market, products must be continuously monitored. Companies are obligated to report incidents, assess risks, and implement corrective measures as needed.
Life Sciences Law provides support with complex regulatory issues, strategic decisions, market entry, market surveillance, and at the interfaces between technology, supply, and regulation. The goal is to create certainty and implement innovations in a legally compliant manner.
contact
Your law firm LIFE SCIENCES LAW - Ralph Schäfer – Lawyer.
- +49 8151 4466683
- ralph.schaefer@lifescienceslaw.de
-
Munich Street 33
82319 Starnberg