Paradigm

Change



Revitalizing Medical Device Excellence: Navigating Change and Confidence

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 In this rapidly changing industry, decisions based on weak data and outdated methods lead to repeated missed objectives and low organizational confidence.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  

View



Regulatory Compliance Solutions for Small-Scale Medical Device Companies

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.

Real World


Problems


Strategic Solutions for Audit-Driven Success

Many audit resources highlight technical deficiencies but lack the practical know-how, often due to outdated or narrow expertise.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.

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

CONEXUS



Revitalizing Medical Device Excellence: Navigating Change and Confidence

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 In this rapidly changing industry, decisions based on weak data and outdated methods lead to repeated missed objectives and low organizational confidence.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.

UNIHUB



Regulatory Compliance Solutions for Small-Scale Medical Device Companies 

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.

EXPERTISE

  • Non-active, Active, and In-vitro Diagnostic and Software MDS like
  • Blood glucose management systems
  • Cardiovascular devices
  • Vascular and gastro-intestinal 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 telemetric 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