ISO 13485 Certification

Kapstone Medical is ISO 13485:2016 certified, meaning that we have been recognized by the International Organization for Standards as being compliant with their international quality standards. For Kapstone, a contractor and consultant firm, this is a unique achievement that underscores our commitment to quality standards. Our subsidiary company, Kapstone Manufacturing, is also ISO 13485 certified.

The of benefits of working with an ISO-certified medical device consultancy include:

• Expert project management that anticipates roadblocks and reduces delays
• Smart risk analysis and mitigation
• User-centric design expertise specific to your patient or provider market
• Established partnerships with compliant suppliers and manufacturers
• Standardized procedures that already confirm to international standards
• Reliable evidence- and experience-based decision-making
• Engaged employees invested in improving their own work and the organization as a whole
• Holistic commitment to excellence, ensuring compliance and efficiency every step of the way

Regulatory Affairs Certificate (RAC)

Kapstone Medical’s regulatory specialists hold the Regulatory Affairs Certificate (RAC), the only post-academic credential available to regulatory professionals in the healthcare industry. In order to earn a RAC, medical device and development professionals must demonstrate knowledge in global regulatory requirements (FDA, CE Mark) and ISO standards. Certification shows that the certified individual can be considered an expert in regulatory affairs.

The benefits of working with a consultancy with a RAC include:

• Intimate knowledge of global regulatory affairs, adaptable to your commercial needs
• Latest regulatory knowledge (the RAC must be renewed every 3 years)
• Familiarity with regulatory bodies
• Logistical know-how to streamline approvals
• The ability to get regulatory feedback proactively, ensuring compliance as early as possible to avoid doubling back (which can be costly)

CAD Certifications

Computer-Aided Design (CAD) Certifications show that an individual is proficient in design and rendering software. Kapstone Medical’s product development engineers utilize the SolidWorks CAD platform and have been certified at the Professional level in Mechanical Design.

The benefits of working with developers certified in SolidWorks CAD program:

• Confidence to create wide range of devices in a variety of production methods
• Maximum time efficiency in designing and modeling concepts
• Integration of design features for optimal prototyping and/or production
• High capability to accurately model, draw, and illustrate designs using various techniques

FDA Registration

The U.S. Food and Drug Administration (FDA) requires all companies involved in the production and commercial distribution of medical devices to complete an annual registration. In order to register, these companies must provide the locations of their various medical device production facilities and descriptions of the devices manufactured at each one. When public, this knowledge ensures that the FDA can efficiently marshal healthcare resources in the event of a national health crisis.

Kapstone Medical (through our subsidiary Kapstone Manufacturing) annually renews our own registration with the FDA which exhibits our compliance in the industry and our comfort to assist our many customers who also need proper establishment registration.