Because I understood a long time ago that the word "business" shouldn't be a taboo but a driving force, Med'In QARA assists medical device sector managers in setting up or developing their company, by combining "business" with quality and regulatory compliance.
Together, we can structure and optimize your quality and regulatory strategy, to guarantee your company's sustainability and growth.
For entrepreneurs wishing to enter the medical device field, Med'In QARA offers support in structuring their project and anticipating quality and regulatory requirements from the outset. This includes developing regulatory strategies and building a solid foundation in quality management, to maximize the start-up's chances of success and rapid growth.
Med'In QARA also assists managers in drawing up business plans that integrate the Quality (QA), Regulatory (RA), Research and Development (R&D) and Clinical dimensions essential to reassure investors and partners. By including realistic objectives, key performance indicators and detailed financial projections, together we create a solid, hard-hitting document.
Because a failing QMS or a shaky technical file constitute industrial risks, it is essential to assess the potential and conformity of a site or product, when making an acquisition or planning an expansion. Med'In QARA carries out targeted QA/RA due diligence, analyzing the site's Quality System, manufacturing lines and processes. This support ensures that each acquisition fits seamlessly into your organization and complies with regulatory requirements.
Diversifying your sources of supply and your processes is an asset for strengthening the resilience of your production chain. Med'In QARA helps you to evaluate additional suppliers, as well as to structure your entry into new markets (Europe, USA, Asia). Audits of suppliers and production sites ensure that each partner is capable of meeting your quality standards.
When business development involves opening new sites or entering new markets, Med'In QARA prepares your teams and facilities for regulatory expectations and audits. This includes assessing and adjusting Quality documentation, and training new staff to ensure that everyone involved complies with the new regulations and understands their role in the new organization.
With Med'In QARA, managers in the medical device industry benefit from strategic support tailored to each phase of their development. This support strengthens the quality, compliance and competitiveness of their operations, while guaranteeing sustainable, structured growth.