We guide you along the most efficient and optimal strategic path throughout your product’s lifecycle.
Innovation is the main key to success for medical device companies in today’s economy. Not only must companies design and produce superior products that completely integrate in the clinical set up, they must also effectively manage each product’s entire lifecycle – from R&D and approvals through manufacturing, distribution and continuous improvement – to achieve success. Strategic regulatory partners specializing in lifecycle management support can provide the skills and resources that medical device companies need to keep up with the demand for efficiency and innovation.
At Qmed Consulting, we offer the best-in-class knowledge, experience and competences from a result-oriented and highly motivated team of global medical device experts in strategic regulatory consulting.
As a full-service medical device Clinical Research Organisation and Consultancy, Qmed assists medical device developer and manufacturer in preparing for the regulatory landscape and commercial market access at key market. The leading edge of Qmed is to prepare and write the Technical Documentation needed and prepare the written procedures to support the proces . Qmed can offer leadership and support the team when navigating the complexity innate to the product approval life cycle. Examples of Qmed’s aptitudes include the following:
Typically, the development of medical devices follows a certain flow from the initial idea to the actual market release.
Initial Market Research
Healthcare Commercial Experts will pinpoint the most promising markets for the product to be validated by the analysis of the Potential Towers methodology.
Commercial Due Diligence
Applies analysis of current market data to translate the product’s clinical and economic advantages into financial value for investors. calculating the targeted market size and potential, validates unmet needs and supports the estimation of sales timelines.
The analysis determines the ideal positioning and pricing model, while clarifying the economically fitted clinical evidence needed in the clinical strategy to achieve and sustain coverage/ reimbursement for the product.
Based on initial market research and Potential Towers data. Planning and product development, testing schemes, documentation, contact to regulatory bodies (EU, US, Canada, India, Australia, Asia) and regulatory submissions.
Based on Reimbursement Analysis to collect economic clinical evidence needed for achieving and sustaining coverage/reimbursement.
Evaluation of clinical data available, determination of need for clinical trials, cost-effective access to market, validation of strategy by consulting authorities and notified bodies.
Project and product specification, risk management, verification and validation testing (including usability and biocompatibility). Through our partners we can act as project manager with validated contract manufacturer that can build prototypes and manufacture.
Classification, biocompatibility, clinical evaluation/literature search, design dossier etc.
Regulatory submissions (such as the EU, the US, Australia and Canada), contact to regulatory bodies including the notified bodies.
Post Market Surveillance Plan
Vigilance, post market clinical follow-up, technical file updating, specialized in EU and US and other regulatory systems.
Commercial due diligence
Commercial due diligence brings an unbiased and factual approach to deliver the required information to support investment decisions.
Development, maintenance and documentation of reimbursement systems, development and implementation of strategies.
Analysis of health care markets for new and existing technologies, collection of primary and secondary market information, verification of findings with Key Opinion Leaders.