Customer Centric Product Creation

  • Dedicated project managers.
  • International teams from around the globe.
  • Customer centric collaboration.

SHL Healthcare assesses every project and dedicates the most suitable team to manage the contract development and manufacturing task at hand. This  can be a full development project, one that leverages an existing modular system, or a development and manufacturing request with fixed specifications / existing products.

FULL DEVELOPMENT PROJECT

For customers who are looking for customized projects with completely new specifications, we set up specific development teams to work closely with them to develop and refine the product from early design concept to the end-product and production.

Modular
Systems

By utilizing our collective experiences and available development and manufacturing capabilities, we invest continuously to provide modular systems and off-the-shelf solutions for customers who prefer to work with such business model.

Realization of Existing Products

Our range of in-house development and manufacturing expertise is part of our core strength. Thus for customers that just need a development and manufacturing partner, we will manufacture and deliver their products exactly per their design, drawings and any other requirements.

  1. Inquiry
  2. Pre-Project
  3. Development
  4. Market Release
    • Pre-Project analysis.
    • Gather information about the potential project, technical & business.
    • Compile related specifications & map out possible product development scenarios.
    • Jointly work on development project SOW (Statement of Work).
    • SHL provided services.
    • Timeline / Deliverables / Target Price.
    • MRS/URS work as input.
    • Development Agreement.
    • Work progress according to SHL QMS.
    • Lead by allocated PM from SHL and customer.
    • Closer cooperation with the customer in Design and Development Planning, Risk Management Planning and finalizing the Design Input Requirements.
    • Released DHF + DMR.
    • Supply Agreement.
    • Forecast.

Market Awareness

Market trend • Regulatory surveillance • Key conference participations

Awareness of market needs allows SHL Healthcare to introduce products accordingly. We attend key conferences & tradeshows and initiates global regulatory surveillance to meet local market requirements. Such activities support us in obtaining market awareness, providing guidance to customers in developing the right products.

Quality
Systems

  • ISO 13485 compliant quality management system
  • Company-wide quality program
  • Corrective and preventive action program

We provide years of accumulated experience in areas of Medical device Quality Assurance, Regulatory Affairs & Compliance, and can support our customers with when it comes to any relevant practices or submissions.

Strong
Expertise

We provide expertise in how to apply the QMS at its’ best and most efficient way with customer’s need in focus. Our Quality and Regulatory department enforces our customer’s ability to act and stay present in the global MedTech industry.

Strict Quality
Management System

We work extensively with our Quality Management System, which complies to ISO 13485, the Medical Device Regulation and FDA 21CFR part 820, ensuring the customer delivery to be of quality and regulatory compliance.

Active
Surveillance

We actively conduct surveillance of trends and changes in the regulatory landscape. This brings valuable market awareness of high significance in our partnership with customers.

Global Logistics

  • Warehouse solution in Sweden.
  • Flexible global logistics solution & enhancing speed to market.
  • Different delivery options.

Warehousing is provided in-house and also outsourced to vendors with specialized services. SHL Healthcare provides one main warehouse solution on the west coast of Sweden. By doing so, we optimize shipments from China by combining several customer’s deliveries weekly, thereby offering products directly from Europe to provide a shorter delivery time to the European market.

Customized Shipping

SHL Healthcare customizes its shipping services to suit the needs of our international customers in a number of ways.

Shipping Partners

We collaborate with existing shipping companies, shipping via air/sea/train (rail) to designated locations.

Warehouses in EU & Asia

SHL Healthcare has warehouses in Europe and Asia, working directly with shipping companies in those regions.

Just-in-Time Inventory

In addition, SHL Healthcare has Just-in-time inventory (JIT) experience that is utilized to assist our customers to better manage in-process inventory.

Customization

Customer Collaboration • Flexible services • Fast delivery time

SHL Healthcare ensures flexibility along the project development process by paying close attention to customer needs. Our engineers are dedicated to finding optimized solutions based on customer requirements. Close collaboration with each customer allows us to ensure that project requirements are identified and targets are met. Our capabilities include handling orders of individual or special slings. Also, client requirements for large volume or one-time orders can be met through custom requests.