It is know that Medical devices have long as well as highly regulated life cycles. Most manufacturers handle their devices in market properly with measures like routine and reactive quality, complaint handling and safety. Some additional proactive activities can help manufacturers prepare better for device marketability, competitiveness and reduce disruptions.
In healthcare domain, Compliance with the HA/NB guidelines and focus on public safety will make an organization a trusted partner. At each stage of Product life cycle, manufacturer must evaluateperformance data of Medical technology and advancements without compromising standards of safety and effectiveness. Our LCM operating model constantly evaluates the problems and safety issues for devices in similar classes and in same therapeutic areas based on indications of use. By constantly reviewing the horizon, you can anticipate the challenges faced by other manufacturers which help you to act proactively to take steps to reduce potential risks and also take advantage of market gaps caused by your competitors because of their reactive processes.
Different companies will adopt different strategies in response to new regulations and to simplify the rules by improving transparency and product traceability. A strategic approach is important for manufacturers to proactively prepare for the regulatory changes. Our LCM operating model provides the solution by delivering the right mix of people and regulatory knowledge to prepare well for newer challenges and create new value for manufacturers. We proactively monitor the upcoming regulatory changes in areas such as License maintenance, Regulatory operations and Therapeutic related changesindifferent countries where your products are being marketed.These will have direct impact on manufacturer’s current and future revenues.
Instead of dealing with multiple contractors or vendors for each of your different needs, MakroCare can provide an integrated life cycle services. LCM program helps you to minimize operational costs and maximize productivity.