Medical Device Consulting Services
- Product development advisory support
- Clinical and Regulatory strategy
- Country specific, product specific road-mapping and advisory
- Compliance and Risk Management consulting
Product development advisory support
Companies developing new medical device products can come across many unforeseen roadblocks or hurdles during the development of new or existing technologies.
Whether companies are working on their first ever product or established companies working improving their products, can face challenges during the development process.
Some of the common areas of challenges could be related to
- Skills or Experience
- Access limitations
MakroCare has been helping various medical device developers, by hand-holding and guiding them through such challenges and advising while developers work on taking their products to the next level in the product realization and commercialization cycle.
Our experts have hands-on depth of experience along with the breadth of exposure to analyse the larger picture have successfully helped companies navigate various challenges in their product development life cycle.
Clinical and Regulatory strategy
Especially for New products or preparing for launching the products for new indications or geography, syncing the regulatory and business strategy is very important.
For new products defining Target Product profile that would be reduce the time to market, as well as allow the businesses, keep the competitive factor for the product in the market, is a critical balance which can be achieved with proper planning.
Similarly, the right clinical strategy that suites the regulatory and business requirements can drastically reduce budgets and duplications, while have maximum output in terms of providing the clinical evidence.
MakroCare guides and provides 360 degree perspective and guidance to medical device developers to achieve maximum ROI on their regulatory and clinical research efforts.
Country specific, product specific road-mapping and advisory
Each Country has its own regulatory system for accessing the safety and effectiveness of medical device that are commercially distributed to the local population.
Even for products that have successful track record of commercial usage in other countries may fall short on the information or compliances specific to an international market’s regulation.
Helping on reviewing existing state of the product and providing the right regulatory market entry roadmap and also consulting on the relevant compliance requirements, in a comprehensive view to being with can help companies plan their effort far easily and efficiently, and reduce time to market and hurdles with the local health agencies.
Having worked with health agencies from various parts of the world as well as the experience on the breadth of medical device technologies and their compliance requirements, allows MakroCare to assist medical device companies with the planning activities and increase the efficiency of the planning efforts.
Compliance and Risk Management consulting
Companies with Single product or with multiple product; having market approval is only one small part of the complete equation. For the commercial distribution of finished products it is of utmost importance to maintain compliance to various standards relevant to the product and geography.
Another important area by which Health Authorities look at quality assurance of the commercially distributed products is by assessing the risk management processes and how robust those systems are. Managing these Quality assurance requirements and Risk management effort could lead to various unnecessary issues. For this purpose looking for ways to improve the compliance framework is very important as it is always a cost intensive area.
MakroCare has been helping companies with product level compliance and risk management as well as management consulting support to improve upon their existing systems to be more robust as well as leaner.