WELCOME TO NEW LEVEL HEALTH

New Level Health Consulting provides professional support to the Health Industry and Medical Device Companies, with comprehensive one-stop shop services ranging from support for product R&D through to the marketplace. The capabilities of selected resources and the team includes extensive experience in :-

• Cross cultural project management

The Team has a particular strength and valuable experience in cross cultural project management especially between Greater China, Europe and the US. Which given the increase in the complexity of the market and product development projects, it is particularly important to ensure that the right tools and practices are brought into play to ensure effective communications and smooth progress.

• Training and development solutions

Given the complex, diverse nature of the industry it is critical to remain up to date with the latest international trends and changes in regulatory requirements. Also as companies develop more complex devices it is critical to ensure that all the risks are fully appreciated and appropriately managed. The Team can provide a range of training and development solutions to compliment or supplement existing resources with specialist support.

• Global markets

It is vital to maintain a good understanding of the marketplace and how to work with it. The Team is able to provide specialist support in how to most effectively access different markets along with innovative strategies for market development. In parallel with this a better understanding can be provided on how to work with complex purchasing and reimbursement systems.

• Production and quality systems

To manage an ever increasing pressure to reduce costs, whilst maintaining or improving quality systems is an ongoing challenge. Having a fresh perspective through an experienced external resource can help bring about the required changes and implement a culture of continuous improvement. The cost of doing so can easily be outweighed through the competitive advantage gained and having robust quality systems that can be trusted.

• Risk Management

The importance of early and continuous evaluation of a product’s hazard potential is well appreciated. Although identifying all of the potential hazards and their likelihood often require special experience with a multidisciplinary background. The NLH Team can bring an enhanced perspective to a company to ensure more comprehensive risk management through further assessment and the implementation of proven tools.

• Health & safety regulatory compliance

Spending on achieving compliance in Health & Safety is often regarded a non productive use of companies resources. The NLS Group of companies firmly believe that by embracing health & safety into a company it can increase efficiency and productivity, providing the right methodology and processes are adopted.

• ISO 13485 & FDA standards /GMPs compliance

With higher risk products and services compliance with international standards is an ongoing challenge. Especially as standards evolve and change to the demands of the industry. It is critical to obtain the right support to ensure an up to date understanding on an international scale, as failure to do can lead to very costly and damaging restrictions on a company’s plans.

• Product design evaluation & material selection

From the early stages of innovation and product design it can be very advantageous to have input from external expertise and know how to bring in a greater level of understanding of critical areas in the market and the end user to ensure the best fit. This can include such areas as biocompatibility and materials selection to avoid issues further down the road in the development process.

Our aim is accelerate products into the market place, whilst achieving full compliance to regulatory requirements and with the best performance at a competitive price