Our Services
Discover a comprehensive range of specialized services to support your medical device projects, from monitoring legislation and technical standards, to technical documentation and quality management system implementation, to a comprehensive regulatory strategy.
Our team of experienced professionals is committed to guiding you every step of the way and ensuring your success in the dynamic world of medical devices.
Market Access
We support manufacturers and distributors to enter the market quickly and efficiently, including securing reimbursement from public health insurance. Together we identify opportunities and barriers to unlock the potential of your medical devices. We look for the right positioning of your device in the system. We prepare BIAs and pharmacoeconomic analyses as required. We work closely with KOLs and professional societies.
Conformity Assessment
We prepare technical documentation for medical device manufacturers and guide them through the conformity assessment process. From pre-clinical assessment, biocompatibility assessment, risk management documentation to complete clinical evaluation documentation. For start-ups, we usually prepare documentation on a turnkey basis. We have in-house experts for all parts of the technical documentation.
IVD Medical Devices
We have specialists in the field of in vitro diagnostic (IVD) medical devices. We provide comprehensive support for manufacturers preparing for IVDR CE-marking and in particular certification by a notified body. We also support manufacturers in the area of functional competence assessment, from documentation of scientific validity, analytical function to demonstration of clinical function.
Software
Software manufacturers have very specific starting conditions. We guide developers of standalone software (SaMD) through the challenging CE marking process from qualification and classification to clinical evaluation. From previous projects we already know what usually represents a problem and misunderstanding. We can extract the best from the specifics of software design and development and build on the advantages.
Clinical Investigation
We provide clinical investigation for CE-marking of medical device. From clinical investigation design, basic statistical calculations, synopsis, to clinical trial plan, investigator's brochure, CRF and other documents to complete dossier for clinical investigation approval. We also perform the monitoring of the clinical investigation and of course the statistical processing and writing of the final report.
Postmarket Surveillance
The planning and implementation of PMS activities are an integral part of the responsibilities of medical device manufacturers. We prepare PMS plans for manufacturers. Together with manufacturers, we actively collect market feedback and statistically evaluate it. The PMS evaluation includes an advanced methodology for monitoring and evaluating trends.
Support of Aesthetics
We provide comprehensive support to beauty salons and aesthetic medicine practices in clarifying the line between cosmetic and medical services. We will ensure that your aesthetic services are delivered through legal products and that you receive the appropriate regulatory documentation from your suppliers. Our services will enable you to provide quality and safe care in accordance with the latest standards.
Law Services
Legal services for our clients are provided by our sister law firm Porta Medica Legal. The Porta Medica Legal has long specialized in the field of medical devices and related areas of law. The law firm shares communication office spaces with Porta Medica, which simplifies intensive cooperation on joint projects. We are therefore able to provide legal representation in administrative proceedings and lawsuits, or the processing of legal opinions through our business friends.
Legal Services
We provide legal services for our clients in cooperation with our sister law firm Porta Medica Legal, which has long specialized in medical devices and other related areas of medical law. Thanks to our close connection and shared offices, we can offer you a comprehensive service for all your business plans.
Public Contracts
We provide advice in the field of public contracts for the purchase of medical devices and IVDs. We help contracting authorities - providers of health services - to formulate procurement documentation in such a way that it includes relevant requirements for funds (risk class, legal regime, fulfillment of the legal definition of ZP/IVD) and for suppliers (checking the status of registration, notification and regulatory documents). We help suppliers complete the offer, provide the required documentation and communicate with manufacturers and contractors.
Marketing and Advertising
Advertising activities in the field of medical devices and IVDs are governed by strict rules at the European and Czech level. When creating marketing materials and advertising campaigns, it is necessary to know not only the legislative requirements, mandatory requirements and prohibited practices, but also the current interpretation opinions and decision-making practice of the regulator. We will help you with the creation of websites, posts on social networks, printed materials and information brochures for experts and the general public. We will review your media output to ensure that it complies with applicable legislation and help you with your overall communication strategy towards subscribers and users.
Reimbursement
We help manufacturers navigate the area of price and reimbursement regulation. We will identify which category your medical device falls into - whether it is a voucher device, a separately billed material, or a large piece of equipment - and accordingly present possible scenarios for obtaining reimbursement from public health insurance funds. In cases of innovative medical devices for which there is still no adequate performance, we will advise you on how to proceed. As needed, we prepare BIA and pharmacoeconomic analyses, we work closely with professional societies and professional organizations. We also provide support in communication with the regulator, help avoid price crimes and prepare strategies on how to increase prices and reimbursement of funds over time.
Other Legal Services
We will provide all the necessary legal support for all your projects in the field of medical devices, whether you need to draw up contractual documentation, a legal opinion, or represent you in administrative proceedings or litigation. For manufacturers of medical devices and their authorized representatives, we externally provide the function of person responsible for compliance with legal regulations (PRRC). However, we also provide legal services in the field of medicinal products, where we specialize in the rules of advertising and marketing and the regulatory obligations of manufacturers, distributors and health service providers. We actively participate in the development of legislation in the field of regulation of medical devices, where we mainly focus on reaching a consensus or compromise between economic entities and state institutions.
Market Access
We support manufacturers and distributors to enter the market quickly and efficiently, including securing reimbursement from public health insurance. Together we identify opportunities and barriers to unlock the potential of your medical devices. We look for the right positioning of your device in the system. We prepare BIAs and pharmacoeconomic analyses as required. We work closely with KOLs and professional societies.
Conformity Assessment
We prepare technical documentation for medical device manufacturers and guide them through the conformity assessment process. From pre-clinical assessment, biocompatibility assessment, risk management documentation to complete clinical evaluation documentation. For start-ups, we usually prepare documentation on a turnkey basis. We have in-house experts for all parts of the technical documentation.
IVD Medical Devices
We have specialists in the field of in vitro diagnostic (IVD) medical devices. We provide comprehensive support for manufacturers preparing for IVDR CE-marking and in particular certification by a notified body. We also support manufacturers in the area of functional competence assessment, from documentation of scientific validity, analytical function to demonstration of clinical function.
Software
Software manufacturers have very specific starting conditions. We guide developers of standalone software (SaMD) through the challenging CE marking process from qualification and classification to clinical evaluation. From previous projects we already know what usually represents a problem and misunderstanding. We can extract the best from the specifics of software design and development and build on the advantages.
Clinical Investigation
We provide clinical investigation for CE-marking of medical device. From clinical investigation design, basic statistical calculations, synopsis, to clinical trial plan, investigator's brochure, CRF and other documents to complete dossier for clinical investigation approval. We also perform the monitoring of the clinical investigation and of course the statistical processing and writing of the final report.
Postmarket Surveillance
The planning and implementation of PMS activities are an integral part of the responsibilities of medical device manufacturers. We prepare PMS plans for manufacturers. Together with manufacturers, we actively collect market feedback and statistically evaluate it. The PMS evaluation includes an advanced methodology for monitoring and evaluating trends.
Support of Aesthetics
We provide comprehensive support to beauty salons and aesthetic medicine practices in clarifying the line between cosmetic and medical services. We will ensure that your aesthetic services are delivered through legal products and that you receive the appropriate regulatory documentation from your suppliers. Our services will enable you to provide quality and safe care in accordance with the latest standards.
Law Services
Legal services for our clients are provided by our sister law firm Porta Medica Legal. The Porta Medica Legal has long specialized in the field of medical devices and related areas of law. The law firm shares communication office spaces with Porta Medica, which simplifies intensive cooperation on joint projects. We are therefore able to provide legal representation in administrative proceedings and lawsuits, or the processing of legal opinions through our business friends.
