Working with us

We take an integrated approach to create a service offering that suits your company and needs.

Cover Biomedical’s services align with all stages of the product development process to assist medtech companies in achieving efficient and effective market entry success.

Our Service Areas

Product & Submission Readiness Assessment

Structured assessment of a device and organisation's readiness to progress toward regulatory submission or key investment milestones. Identifies gaps in design control and risk management, and provides a clear set of prioritised next steps.

Scale-Up Readiness Assessment

Targeted assessment of existing design control and quality systems for more mature organisations. Reviews robustness, regulatory alignment and identifies issues that may create downstream regulatory, cost or delivery risk.

Targeted Gap Analysis

Scoped, stage-specific assessment addressing a defined issue or development stage. Examples include: design control gap analysis, risk management file review, Design History File completeness review, regulatory pathway alignment review, and updated standard impact assessment.

Early-Stage Concept Feasibility Review

Light entry service for founders at the earliest stage of the innovation journey. A review of concept feasibility against regulatory, technical and commercial considerations—before significant investment is made.

Design Control & Risk Management

Bespoke development or remediation of design control frameworks and risk management systems, proportional to device class, development stage and organisational capability. Includes integration into day-to-day engineering workflows and support through design reviews and design freeze milestones.

End-to-End Engineering Design Process

Bespoke full-lifecycle delivery from early concept through to regulatory submission and market readiness. Includes design strategy and planning, engineering development support, design verification and validation preparation, regulatory alignment and submission support, and design transfer.

Design Freeze Readiness Review

Structured review prior to design freeze to identify gaps and risks before they become costly downstream issues. Addresses a common high-risk point in the innovation journey.

Program Management

Bespoke coordination of engineering, quality, regulatory and specialist partner activities across complex, multi-disciplinary development programs. Bridges' technical expertise and execution, supporting delivery certainty and momentum where multiple stakeholders are involved and internal capability is limited or stretched.

Grant Application Assistance

Get the guidance you need to be in the best position to receive valuable grant funding to develop and grow.
Outcomes:
  • Advice following a review of your applications
  • Contribution to the development of grant submissions in alignment with the objectives and criteria of the grant offer.
  • Conduct and document a gap analysis from company input to establish grant eligibility.

Quality Compliance Frameworks

Working with aspiring and established medtech companies, we develop robust Quality Compliance Frameworks.
Outcomes:
  • Assist in establishing an ISO 13485 or MDSAP audit-ready framework.
  • Cultural awareness and skills development.
  • End-to-end process improvement.

Leadership and Support

To support skills and knowledge growth, we provide engineering design and development teams with dedicated, experienced-based support and leadership.
Outcomes:
  • Team development in the context of biomedical engineering design best practice
  • Increased understanding of compliance expectations relevant to engineering outputs.
  • Subject Matter Expert level input into design and development planning and implmentation

Training and Mentoring

FOR EMERGING PROFESSIONALS<br>To support skills and knowledge development, we provide medtech executives, engineering, quality and regulatory teams with dedicated, experienced-based training and mentoring.
Outcomes:
  • Team development inthe context of industry best practices.
  • Increased understanding of compliance expectations and responsibilities.
  • Alignment of roles required to grow your business successfully

Investment Prospectus

We work with Executive Teams to compile an investment prospectus that presents a feasible picture for investors, helping to seek adequate investment.
Outcomes:
  • Peer and expertsreview and assessment of an investment prospectus relevant to health technologyand the associated industry.
  • Assistance with planning a fundraise that is realistic with accurate information relevant to the health technology industry opportunities and constraints, product pipeline ambitions.

Strategy Development

At all stages of the medtech product realisation journey, having a well developed strategy in place is important. Engage us to ensure you have a robust regulatory and markety entry strategy in place.
Outcomes:

End-to-end Engineering Design Process

Ideally suited for start-ups and scale-ups requiring experienced oversight before investment in certification, regulatory submissions or increases in production.
Outcomes:
  • A review of existing processes anddeliverables with an experienced eye to establish any gaps in alignment withbest practices and regulatory expectations.
  • Identification of the key risksand recommend opportunities for process improvements, skills development, andresource investment.
  • Leadership and support to teams to build contextual awareness and best practice capability.

Let's work together

Contact us today
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