Your Allies in MedTech

At our core, we value people. Our employees embody our expertise. Fostering a positive environment allows us to minimize attrition, ensuring the preservation of invaluable knowledge. This positivity extends to clients, turning business relationships into enduring alliances. As our team and clients explore new ventures, we embrace new opportunities.

Our Medical Technology Services

01

Software as a Medical Device

Our team manages the entire medical device software lifecycle including planning, analysis, development, testing, support, documentation, and ensuring compliance with regulatory requirements.

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02

U.S. FDA – 510(k) Submission

We have assisted multiple healthcare clients in the development and documentation of their solutions and have secured 510(k) clearance for over a dozen solutions.

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03

EU MDR – CE marking

In the realm of medical devices and software, EU MDR compliance is a vital element. Our services encompass regulatory strategy, post-market surveillance, ISO certifications, and rigorous safety testing to facilitate the CE marking of medical devices.

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04

SOP Consultation

Our experts rely on years of experience developing medical software to ensure our clients’ operating procedures reflect their needs while meeting the challenges of changing industry trends.

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05

Streamlining Documentation

We have dedicated specialists representing all stages of the software development lifecycle who are well-versed in developing documentation that adheres to the highest standards.

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06

Quality Assurance and Quality Control

Our combined QA & QC services streamline processes, safeguard quality, and ensure regulatory compliance. Backed by a diverse team and expert knowledge, we tackle project challenges for successful market launches.

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Regulatory Affairs

Preparation

We get existing deliverable packages ready for streamlined evaluation by identifying gaps and suggesting ways documentation can be improved.

Maintenance

We prepare previously certified products’ supporting documentation for resubmission, which may be necessary due to significant product changes or to ensure compliance with updated regulations.

Support

We pair software development projects with QA-specific activities. These include ensuring compliance with applicable procedures, advising on process optimization, and reviewing ongoing production records.

Guidance

We provide expertise in FDA and MDR-compliant software development methods to MedTech start-ups and other partners with limited resources to build their own quality and regulatory teams.

Regulatory Affairs

Preparation

We get existing deliverable packages ready for streamlined evaluation by identifying gaps and suggesting ways documentation can be improved.

Support

We pair software development projects with QA-specific activities. These include ensuring compliance with applicable procedures, advising on process optimization, and reviewing ongoing production records.

Guidance

We provide expertise in FDA and MDR-compliant software development methods to MedTech start-ups and other partners with limited resources to build their own quality and regulatory teams.

Maintenance

We prepare previously certified products’ supporting documentation for resubmission, which may be necessary due to significant product changes or to ensure compliance with updated regulations.

Experience Snapshot

GPI

Friendly hospital phlebotomist collecting blood sample from patient in lab. Preparation for blood test by female doctor medical uniform on the table in white bright room

GPI USA

Our web-based software solution adheres to international standards, facilitating the entire journey of blood products from donation to transfusion across more than 50 countries. Key benefits include a device-independent, cost-efficient platform with optimized processes, low licensing fees, and robust analytics tools for enhanced efficiency. The system integrates a Laboratory Information System (LIS) for comprehensive laboratory management, including analytical tests, patient administration, and invoicing. Developed by blood bankers, it includes modules for donor management, pre-donation health history assessment, donor recruitment, and staff scheduling. The solution meets industry standards, prioritizing blood component safety and audit tracking, and addresses the diverse needs of blood banks.

SaMD
Quality Assurance
Regulatory Compliance

Software as a Medical Device

Synthesis-Net is an established provider of regulated software services for healthcare and medical technology companies. Our team manages the entire medical device software lifecycle including planning, analysis, development, testing, support, documentation, and ensuring compliance with regulatory requirements. We create, optimize, and implement effective and transparent processes to ensure medical solutions are approved and reach the market faster.

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Full lifecycle custom software development for medical software (Class I, II, III / A, B, C)
Regulatory compliance with FDA 21 CFR Part 820, ISO 13485, IEC 62304, EU MDR
Compiling 510(k) documentation
Comprehensive CE marking guidance
Drafting standard operating procedures (SOPs)

U.S. FDA – 510(k) Submission

For medical device and software companies, adhering to FDA standards and regulations is both complicated and absolutely necessary. We have assisted multiple healthcare clients in the development and documentation of their solutions and have secured 510(k) clearance for over a dozen solutions.

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Identifying requirements for launching medical device software in the U.S. market
Analysis determining the best approach for securing FDA approval
A streamlined process for compilation of documentation
Support and guidance in reapproval process related to changes in the intended use

EU MDR – CE Marking

In the realm of medical devices and software, EU MDR compliance is a vital element. Our services encompass regulatory strategy, post-market surveillance, ISO certifications, and rigorous safety testing to facilitate the CE marking of medical devices.

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Streamline medical device compliance from strategy to post-market surveillance for CE marking
Access the global medical device market with ISO 13485 certification, while also offering assistance in selecting a notified body
Ensure medical device safety through industry-standard tests and usability evaluations

SOP Consultation Services

Standard operating procedures (SOPs) provide a foundation for building software by identifying precedence, laying ground rules, streamlining processes, and offering the transparency necessary for future optimization. Our experts rely on years of experience developing medical software to ensure our clients’ operating procedures reflect their needs while meeting the challenges of changing industry trends. We can help improve existing SOPs or guide firms in building their own from the ground up.

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Understanding the domain knowledge necessary to identify goals and the procedures necessary to attain them
Compiling comprehensive sets of rules and documentation to withstand the scrutiny of regulatory authorities
Balancing flexibility with standardization to ensure production remains predictable while still being responsive to new development models or technologies

Streamlining Documentation Services

To ensure traceability, documentation for software as a medical device must meet strict regulatory guidelines and deliverables in order to demonstrate readiness for actual use. The written information accompanying a software product must be clear, concise, and meet stakeholder needs. We have dedicated specialists representing all stages of the software development lifecycle who are well-versed in developing documentation that adheres to the highest standards.

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Comprehensive documentation for product planning, release, and everything in between
A wealth of experience in preparing paperwork for various regulatory agencies, including the U.S. Food and Drug Administration (FDA)
Full development teams proficient in English, augmented by expert translators for key European languages
Active knowledge of all the major tools and methods for producing, reviewing, approving, and maintaining product documentation during and after the development process

Quality Assurance and
Quality Control

Our commitment to quality assurance and quality control is fundamental to the success of medical device software. Backed by a seasoned testing team experienced in regulated environments, we prioritize precision in every development phase. Our strategic resource allocation optimizes budgets by focusing on impactful activities. Post-release, our support team operates across multiple tiers, guaranteeing clients ongoing assistance to navigate the evolving technical landscape with confidence and efficiency.

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Enhance testing efficiency and accuracy with test automation
Ensure compliance, functionality, and comprehensive quality through formal, functional and non-functional testing
Technical Support ranging from Tier 1 to Tier 3
Comprehensive Inside Sales and Administrative Support

Why Coose Us

With over 20 years of experience in the U.S. market, our team possesses a deep understanding of FDA and other regulatory authorities’ requirements. This expertise extends to regulated software development and SaMD, Quality Assurance, and Regulatory Affairs domains. Our low attrition levels, coupled with our significant domain knowledge, have allowed us to establish a strong U.S. presence, including dedicated sales resources and consultants.

01

Deep Domain Knowledge

Our team boasts comprehensive expertise in operating within regulated environments, particularly in the realm of SaMD, optimizing outcomes and ensuring compliance.

03

Wide Collaborative Network

Navigate your MedTech journey at any stage – from ideation to launch – through our partners and alliance of experts in the bright hills MedTech Hub.

02

Scalable Solutions

Our solutions are designed to adapt and evolve with your business needs, supporting you at every stage of the Software Development Life Cycle (SDLC).

04

U.S. Market Experience

Backed by over two decades of experience in the U.S. market, our team holds invaluable and extensive industry insight.

Connect with our MedTech Consultants

Dr. Bela Venesz

HQ Hungary
+36 20 468 9806
bvenesz@szintezis-net.hu

Nathaniel Sandys

U.S.
+1 612 743 9103
nsandys@szintezis-net.hu

Stevie Farkas

DACH
+43 677 6299 0045
sfarkas@szintezis-net.hu

Events calendar

MedTech Summit

Join us at the 6th edition of the MedTech Summit – your gateway to the latest in healthcare and medical technology.

Date: February 1st, 2024
Location: Budapest, Hungary

MedTech Summit

Join us at the 6th edition of the MedTech Summit – your gateway to the latest in healthcare and medical technology.

Date: February 1st, 2024
Location: Budapest, Hungary