SaMD
Software as a Medical Device
Developing SaMD products provides companies with new revenue streams, enhanced market position through innovation, and cost efficiencies via scalable systems.
It also allows market expansion and supports strategies to build strong customer loyalty by improving patient outcomes and satisfaction.
What is SaMD?
SaMD (Software as a Medical Device) refers to software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.
SaMD includes applications that aid in diagnosing, monitoring, and treating patients and can range from mobile apps to more complex algorithms used in clinical decision support.
From initial consultation to market entry and post-market surveillance, Medicologic offers end-to-end support tailored to your specific needs.
We help you develop a clear market entry strategy, engage with key stakeholders, and implement systems for continuous monitoring and improvement.
Our team of experienced consultants provides ongoing training and support to ensure your SaMD remains compliant and effective, driving better patient outcomes and enhancing your competitive edge in the Life Science industry.
How to Approach SaMD
As a Life Science company, approaching SaMD involves several key steps:
Market Research and Needs Assessment: Identify unmet medical needs and potential software solutions.
Regulatory Understanding: Gain a thorough understanding of regulatory requirements in target markets.
Development: Invest in robust software development practices that prioritize patient safety and efficacy.
Quality Management Systems (QMS): Implement a QMS to ensure compliance and maintain the high quality of the software.
Clinical Evaluation: Conduct clinical evaluations to demonstrate the software’s safety and effectiveness.
Cybersecurity: Integrate strong cybersecurity measures to protect patient data and maintain compliance with regulations.
How Medicologic Can Assist in the SaMD Process
Initial Consultation and Market Research
- Market Analysis: Medicologic can conduct detailed market research to identify unmet needs and potential opportunities for SaMD solutions. This includes competitive analysis, market trends, and patient demographics.
- Feasibility Studies: Evaluate the technical and commercial feasibility of proposed SaMD solutions.
Regulatory Guidance
- Regulatory Strategy: Provide expert guidance on the regulatory requirements for SaMD in different markets.
- Submission Preparation: Assist in preparing regulatory submissions, ensuring all necessary documentation and evidence of compliance are included.
Development Support
- Software Development Oversight: Offer project management and technical expertise to oversee the development of the SaMD, ensuring adherence to best practices and standards.
- Clinical Evaluation: Design and manage clinical evaluations to demonstrate the safety and efficacy of the SaMD.
Quality Management Systems (QMS)
- QMS Implementation: Help implement a robust QMS compliant with ISO 13485 or other relevant standards, including the development of necessary procedures and documentation.
- Audit Preparation: Prepare the company for internal and external audits, ensuring continuous compliance.
Risk Management
- Risk Assessment: Conduct comprehensive risk assessments to identify potential risks associated with the SaMD.
- Mitigation Strategies: Develop and implement mitigation strategies to address identified risks.
Post-Market Surveillance
- Monitoring Systems: Set up systems for post-market surveillance to monitor the performance and safety of the SaMD after it has been launched.
- Feedback Mechanisms: Establish mechanisms for collecting and analyzing user feedback to facilitate continuous improvement.
Cybersecurity
- Security Assessment: Conduct security assessments to identify potential vulnerabilities in the SaMD.
- Cybersecurity Measures: Develop and implement robust cybersecurity measures to protect patient data and ensure compliance with regulations like GDPR and HIPAA.
Road to Market
- Market Entry Strategy: Develop a comprehensive market entry strategy, including go-to-market plans and stakeholder engagement.
- Reimbursement Strategy: Assist in understanding and navigating the reimbursement landscape to ensure the SaMD is financially viable.
Training and Support
- Staff Training: Provide training for company staff on regulatory requirements, QMS, and best practices for SaMD development and maintenance.
- Ongoing Support: Offer ongoing support and consultancy services to address any challenges that arise during the SaMD lifecycle.
Know-how, skills and mindset
At Medicologic we know all about the challenges of finding talent and the right skill-sets for the tasks.
Medicologic was founded in 2000 by the present CEO Michael Funder, and through more than 20 years we have strived to find the greatest talent and the most skilled specialists for the medical device industry.
Our goal is to create the best scenarios for our clients, and combine our talent and specialists with the goals and budgets at hand.
We strive for customer-service excellence – and a part of this is providing a service, that gives our clients full flexibility to pull on our various ressources on any given time.
The expectations in the medical device market are high with increasing focus on patient safety and treatment methods.
Our team of dedicated freelance consultants and specialists help you develop solutions that meet the expectations, requirements and challenges in the medtech and pharma markets.
Contact
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13
contact@medicologic.com
Medicologic-profile
Where to find us
Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com
Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com