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

End-to-end Engineering Design Process

Ideally suited for start-ups and scale-ups requiring experienced oversight on their medtech product development journey before investment in certification, regulatory submissions, or increases in production, in all development phases:

  1. Initiation and Feasibility
  2. Planning, Preliminary Risk Assessment and Strategy
  3. Design & Development
  4. Verification and Validation Planning & Implementation
  5. Transfer to Manufacture Planning & Commercialisation
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  • A review of existing processes and deliverables with an experienced eye to establish any gaps in alignment with best practices and regulatory expectations.
  • Identification of the key risks and recommend opportunities for process improvements, skills development, and resource investment.
  • Leadership and support to teams to build contextual awareness and best practice capability.

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 market entry strategy in place.

Investment Advice

We assist investors with understanding the industry and what is presented in the prospectus as feasible.

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  • A subject matter expert’s review and assessment of an investment prospectus relevant to health technology and the associated industry as part of a potential investor’s due diligence.
  • Understanding of different stages and expectations of the medtech development process

Investment Prospectus

We work with Executive Teams to help compile an investment prospectus that presents a feasible picture for product development investors and adequate funding for businesses.

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  • Peer and experts review and assessment of an investment prospectus relevant to health technology and 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.

Training and Mentoring

for emerging professionals

To support skills and knowledge development, we provide medtech executives, engineering, quality and regulatory teams with dedicated, experienced-based training and mentoring.

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  • Team development in the context of industry best practices.
  • Increased understanding of compliance expectations and responsibilities.
  • Alignment of roles required to grow your business successfully

Leadership and Support

for design and development teams

To support skills and knowledge growth, we provide engineering design and development teams with dedicated, experienced-based support and leadership.

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  • 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

Quality Compliance Frameworks

Working with aspiring and established medtech companies, we develop robust Quality Compliance Frameworks.

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  • Assist in establishing an ISO 13485 or MDSAP audit-ready framework.
  • Cultural awareness and skills development.
  • End-to-end process improvement.

Grant Application Assistance

Get the guidance you need to be in the best position to receive valuable grant funding to develop and grow.

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  • 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.

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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