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Software Development, QA, QMS, Program Management, Marketing

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Medical Device Software Development compliant to ISO 13485

With the new generation of medical devices, the software content in the devices is ever increasing. Camensys with its team of IoT and Machine Learning experts is uniquely positioned to develop the full stack development of the medical device systems including:

  • Firmware and Embedded Systems

  • Mobile App communicating with medical devices

  • Streaming data communication to cloud

  • Machine Learning model development

  • Edge processing at the device for fast and critical actions

Camensys software design and development process is compliant to ISO 13485 quality standard, ISO 14971 risk management standard and IEC 62304 medical device software development lifecycle standard to make the medical device manufacturer ready for FDA approval from day one.

 

Camensys offers development services for any new generation medical devices that are newly categorized by FDA as either Medical Device Software or Software as Medical Device (SaMD).

Take an assessment test: "Are you ready for FDA"

Regulatory Affairs and Tool-based Quality Management System (QMS)

Camensys can help a medical device software manufacturer in planning, designing, implementing, and enforcing a low overhead Quality Management System (QMS) that works with various teams of the company. Camensys services include:

  • Complete FDA regulatory affairs - approval planning, preparation and submission process

    • FDA and EU submission support

    • Regulatory Affairs and best practice evaluations and roadmaps

  • Process and technology validation development and execution

  • Developing Quality Management System (QMS) to comply with FDA Quality System Regulations (QSR) including 21 CFR Part 820, ISO 13485 for quality standard, and ISO 14971 for risk management standard.

  • Software development process (ALM) as per FDA prescribed ISO 62304.

  • AI and Machine Learning framework using FDA’s Good Machine Learning Practice (GMLP).

  • Creating QMS tools requirements, tools comparison and recommending appropriate tools.

  • Developing Standard Operating Procedures (SOP) incorporating various tools used for design and development of the medical device software.

  • Managing the quality system operations on a day to day for the company.

Often the new generations of high-tech medical device companies with innovative technologies get worried because of the requirements of the quality and FDA compliance. Camensys will hand-hold the company and its team members at every step for creating the roadmap and carrying the company to the final goal through the FDA approval and beyond.

Take an assessment test: "Are you ready for FDA"

Product and Program Management for medical device system development

The modern high-tech medical devices are complex systems incorporating various electro mechanical and electronic hardware and software components. Each of these components might be designed and developed by different teams distributed globally. With various standards of quality (and sometimes no defined standard) followed by each of these teams it is important to manage all these projects within a single program with well-established consistent quality assurance standards.

  • The end-to-end product management including marketing specifications, system requirements documentation, user experience (UX) design, product ownership, product roadmap optimization and prioritization.

  • Developing a traditional or agile program and project management framework for synchronous development of multiple distributed teams.

  • Setting up tools and processes for product and project management in synchronization with development teams.

Digital Marketing for medical device manufacturer

Camensys Digital helps medical device manufacturing companies in developing go-to-market strategy, branding, web site development, marketing automation for lead generations, social channel messaging and all things digital marketing. Especially for medical device startups Camensys Digital can act as the in-house end-to-end marketing team including the role of Chief Marketing Officer (CMO) at a fraction of a cost of a full-time CMO only.

  • Marketing Strategy focusing on brand development, market positioning, competitive analysis, lead generation and short-term tactical and long-term strategic planning.

  • All creative development including corporate logo, web site, brand style sheets, various templates like newsletters, presentation.

  • Content development including whitepapers, blogs, infographics, animation videos.

  • Marketing automation with orchestrated content marketing, email campaign, website visitor tracking and lead scoring.

  • Public and media relation with press releases, getting interviews with relevant industry publications, publishing byline articles in publications and be the mouthpiece for the brand and technology.

Take an assessment test: "Are you ready for FDA"