COMPANY PRESENTATION
TABLE OF CONTENT
Welcome Message
Executive Summary
Video Presentation
4
16
27
About Us
Mission
Vision
How
Mantra
7
Meet The Team
Expertises
Services
Paradigm change
Small world view
Real world problems
Products
Conexus
Unihub
Who we serve
Regulatory Agencies
Attorneys
Medical Device Organizations
Academic Research Organizations, Innovators, Physician-Inventors, Early-Stage and Start-up Companies
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24
Client Engagement
36
PRISMA COMPLIANCE
Advancing Healthcare for Public Benefit
WELCOME MESSAGE
Welcome to Prisma Compliance: Guiding Excellence in Medical Devices
We are delighted to have you learn more about our company. At Prisma Compliance, our mission is to empower the medical device industry with knowledge and expertise, always dedicated to ensuring patient safety and quality of care. We strongly believe that the healthcare should never compromise on these core principles.
Let's embark on this journey together.
EXECUTIVE SUMMARY
Franz Israel
Prisma Compliance is a pioneering public benefit organization committed to addressing the pressing challenges in the healthcare sector through innovative and meaningful solutions. Our core principles are deeply rooted in addressing real-world issues and fostering collaboration to drive progress in the medical industry. With the clear objective to enhance the productivity of medical organizations and facilitate an efficient bench-to-bedside process, Prisma Compliance has embarked on a journey to make a significant impact on healthcare for the betterment of society.
Co - Founder
VIDEO PRESENTATION
Prisma Compliance ~ Concise. Correct. Complete.
Double click on image to autoplay
ABOUT US
Prisma is passionate about helping medical device organizations like yours to navigate the intricate world of regulatory health with confidence and precision. I am reaching out to you to share more about how Prisma Compliance can make a substantial impact on your regulatory health strategy
ABOUT OUR
COMPANY
Prisma Compliance’s focus is the provision of knowledge and expertise to the medical device industry to ensure patient safety and quality of care.
Unlike consulting firms, this organization is primarily a knowledge hub that provides information, resources, and expertise to help organizations navigate complex regulatory frameworks and ensure their compliance with global standards. By providing access to up-to-date information, best practices, and expert insights, this organization can help organizations improve their products, processes, and services while ensuring patient safety and ultimately the quality of care.
OUR VISION IS IMPORTANT
At Prisma Compliance, our vision is to be the beacon of excellence in the medical device industry, guiding organizations towards a future where patient safety and quality of care are never compromised.
We aspire to empower the medical device community with the knowledge, innovation, and precision necessary to navigate the intricate world of regulatory health.
Our commitment is to help our clients achieve a robust, sustainable regulatory foundation while ensuring the well-being of patients is at the heart of every endeavor.
OUR MISSION
To empower the medical device industry with knowledge and expertise to ensure patient safety and quality of care
HOW
The techniques we offer in order to build a distinguishable and
long-lasting strategy to significantly improve their regulatory health
We employ a novel and innovative approach that transcends conventional compliance solutions. Our methodology is designed to adapt and evolve with the ever-changing regulatory landscape, ensuring that your strategy remains valid.
Systematic Excellence
Innovative Methodology
Prisma uses a systematic approach that simplifies the complexities of regulatory compliance. Our streamlined processes save you valuable time and resources, enabling you to focus on what truly matters - patient safety and quality of care.
Here's why Prisma is your ideal partner in this journey
Validated Resources
Our arsenal of tools is rigorously validated to guarantee their effectiveness in assessing and enhancing your regulatory health. With Prisma, you'll have access to the most reliable resources for your regulatory journey.
Curated Expertise
Our team comprises industry experts with decades of experience. When you partner with Prisma, you gain access to a wealth of carefully curated expertise to guide you through the regulatory maze.
Integrated industry proven state-of-the-art tools can streamline your processes, improve data quality and enable timely responses to colleagues, project managers, and external parties, so your product registrations, regulatory submissions and knowledge management are optimized.
Proven Technology
MANTRA
To maximize our positive impact and deliver excellence every day, we follow this mantra
OUR MANTRA Navigating Complexity with Prisma
COMPLETE
The medical device regulatory environment has been chaotic in recent years, making it hard to keep pace in this fast-moving industry. Many now feel like they're watching a train they can never catch. Prisma Consulting helps organizations gain and maintain the confidence and trust required to engage effectively with regulatory bodies.
CORRECT
The consultant industry has grown rapidly, offering grand promises but often lacking practical tools and consistent problem-solving approaches. Many consultants bill by the hour without providing substantial knowledge transfer. In some cases, consultants introduce ineffective solutions, inflate systems, and disregard an organization's decision-making process.
CONCISE
Prisma offers expert, hands-on solutions tailored to your organization's specific needs. We avoid generic approaches, theoretical concepts, and buzzword-filled proposals. Instead, we deliver robust solutions that empower your organization to continue with the strategy you choose from our scenarios. We prioritize self-sufficiency and value, not invoicing.
Empowering Your Vision with Prisma's Precision Solutions
Navigating with Clarity in a Crowded Consulting Landscape
Your Track to Regulatory Confidence
MEET THE TEAM
Our seasoned and diverse team is boasting a minimum of 25+ years of collective experience, along with collaborators and combining forces with a group of fresh minds in high-tech and customer service, you have curated and holistic expertise at your fingertips.
OUR TEAM
Prisma’s team is passionate about their work and dedicated to contributing to the improvement of healthcare. A diverse team, augmented with collaborators and partners, Prisma is boasting decades of experience. Combining forces with a group of fresh minds in industry and education, all projects are carefully analyzed for the competencies required by Prisma. Together, Prisma Compliance brings a wealth of knowledge, a range of perspectives, and the skills that can drive truly innovative thinking, enrich your company culture, and make a lasting impact. Unlike consultancy, Prisma is driven by a mission to serve the public good and assure employee success. This means Prisma commits itself to transparency, accountability, and responsiveness to the needs of our clients. This empowers the team to bring a range of benefits to their customers, including access to specialized expertise, a commitment to social responsibility, and a focus on long-term sustainability. Prisma teams are professional, engaging, and always invested in customer success. They deliver results that are meaningful, reproducible and relevant.
EXPERTISE The Prisma Team Prisma Compliance operates in an extraordinary environment of subject matter expertise including:
EXPERTISE
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△ Non-active, Active, and In-vitro Diagnostic and Software MDS like:
△ Blood glucose management systems
△ Cardiovascular devices
△ Vascular and gastrointestinal devices
△ Ophthalmic and joint implants
△ Transfusion and infusion devices
△ Acute and urgent care monitoring devices
△ General surgery products
△ Dental materials
△ Drug delivery devices
△ In-vitro diagnostic assays, reagents, and test kits
△ Wound dressings
△ Powered and non-powered surgical instruments
△ Imaging devices
△ Devices for minimally invasive surgery and endoscopy
△ Devices for gynecological, nephrological, neurological, neurovascular, biliary,
urological, and electrosurgical applications
△ Software (SAMD, SIMD, digital apps, and telemetry applications)
△ Device interoperability and cybersecurity
△ Specialty subject matter like biocompatibility, drug development, sterilization
methods, environmentally controlled rooms, cleanliness, and tissue of animal origin
△ Risk management
△ Translational research
△ Business operation
△ Healthcare
OUR SERVICES
Elevate your medical device business with our comprehensive services
Paradigm
Revitalizing Medical Device Excellence: Navigating Change and Confidence
change
Many long-standing organizations in the medical device industry suffer from fragmented knowledge and employee turnover, leading to difficulties in project execution and a reliance on anecdotal memory. Regulatory expertise often lacks adaptability and long-term vision. In this rapidly changing industry, decisions based on weak data and outdated methods lead to repeated missed objectives and low organizational confidence. We help your organization break this cycle, providing clarity and guidance for sustainable success.
Small World
Regulatory Compliance Solutions for Small-Scale Medical Device Companies
View
Many small medical device companies face budget constraints and limited resources, making it challenging to acquire the necessary regulatory expertise. To sell products, small organizations must demonstrate compliance, just like medium to large companies. The main challenge for small-scale organizations is balancing quality and growth, which can be a complex issue. Understanding regulatory requirements within the context of quality systems can seem like an overwhelming additional responsibility for existing staff. We help your organization break this cycle, providing clarity and guidance for sustainable success.
Real World
Strategic Solutions for Audit-Driven Success
problems
Many audit resources highlight technical deficiencies but lack the practical know-how, often due to outdated or narrow expertise. Finding innovative solutions demands agility, creativity, and costly resources. Adopting another organization's approach is risky. Success relies on a strong foundation, strategic focus, and effective communication. We help your organization break this cycle, providing clarity and guidance for sustainable success.
PRODUCTS
Empowering Success in Medical Device Industry: Conexus for established excellence, Unihub for small-scale innovation – Breaking barriers, providing clarity, and elevating regulatory expertise for sustainable growth
Revitalizing Medical Device Excellence: Navigating Change and Confidence
CONEXUS
Many long-standing organizations in the medical device industry suffer from fragmented knowledge and employee turnover, leading to difficulties in project execution and a reliance on anecdotal memory. Regulatory expertise often lacks adaptability and long-term vision. In this rapidly changing industry, decisions based on weak data and outdated methods lead to repeated missed objectives and low organizational confidence. We help your organization break this cycle, providing clarity and guidance for sustainable success.
Regulatory Compliance Solutions for Small-Scale Medical Device Companies
UNIHUB
Many small medical device companies face budget constraints and limited resources, making it challenging to acquire the necessary regulatory expertise. To sell products, small organizations must demonstrate compliance, just like medium to large companies. The main challenge for small-scale organizations is balancing quality and growth, which can be a complex issue. Understanding regulatory requirements within the context of quality systems can seem like an overwhelming additional responsibility for existing staff. We help your organization break this cycle, providing clarity and guidance for sustainable success.
WHO WE SERVE
Prisma is passionate about helping medical device organizations like yours to navigate the intricate world of regulatory health with confidence and precision. I am reaching out to you to share more about how Prisma Compliance can substantially impact your regulatory health strategy.
Regulatory Agencies
Your Trusted Partner for Regulatory Validity.
Attorneys
Where Legal Precision Meets Technical Excellence
Medical Device Organizations (MDOs)
Your partner for Medical Device Success.
Academic Research Organizations, Innovators, Physician-Inventors, Early-Stage, and Start-up Companies
Empowering Your Research and Innovation
WHO WE SERVE
CLIENT ENGAGEMENT Embark on a path to regulatory excellence with Prisma Compliance, where each step is a journey to empower your organization and uncover unexpected value along the way
Establishing Confident Partnerships
Solution Design & Delivery
Our journey begins by forging trusted peer-to-peer relationships, where we align on business objectives and strategies for your regulatory health.
We then design and deliver tailored solutions, empowering your organization with the tools, processes, and expertise needed to navigate regulatory challenges effectively.
With a solid partnership in place, we take an independent perspective, conducting a comprehensive assessment of your organization's regulatory landscape.
We measure the results of our intervention, helping you create a culture of continuous improvement while building a track record of success.
Prisma's Cycle to Regulatory Health Excellence
Organizational Assessment
Measuring Impact
CONTACT US
120 Washington St.
Salem, MA 01970
USA
+1 (781) 222-4484
info@prismacompliance.com
www.prismacompliance.com
No matter where you currently stand on your path, we are here to assist you achieve optimal success.
THANK YOU
Glad to meet you, see you soon!
This presentation has been prepared for general guidance on matters of interest only, and does not constitute professional advice. You should not act upon the information contained in this presentation without obtaining specific professional advice. Prisma Compliance Corp. its members, employees and agents do not accept or assume any liability, responsibility or duty of care for any consequences of you or anyone else acting, or refraining to act, in reliance on the information contained in this presentation or for any decision based on it. © 2023 Prisma Compliance Corp. All rights reserved.