Leading Developer & Manufacturer of Alternating Pressure Mattress Systems, Patient Slings & other Medical Soft Goods Products

Follow us on

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 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.

Refinement of Existing Products

Expert input to optimize design/cost etc.

Realization of Existing Products

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

  1. Inquiry
  2. Pre-Project
  3. Execution
  4. Production
    • Pre-Project analysis.
    • Gather information about the potential project, technical & business.
    • Compile related specifications & map out possible product development scenarios.
    • Understand customer needs.
    • Jointly work on development project SOW (Statement of Work).
    • SHL provided services such as early prototypes, samples & initial testing.
    • Timeline / Deliverables / Target Price.
    • Requirement work as input.
    • Customer Agreement.
    • Work progress according to SHL/Customer 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.
    • Executing project tasks as planned i.e. design, prototyping, verification, process validation.
    • Release DMR & Establish DHF.
    • Support Agreement.
    • Pilot series.
    • Ramp up.
    • Change request / Change order.

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.

ISO13485 Certificate. Medtech Manufacturing by SHL Healthcare.

Quality and Regulatory Compliance

SHL Healthcare is compliant with ISO 13485 regarding the
management system and are compliant with all relevant
international standards for test methods/equipment’s as
well as product development and manufacturing.

ISO Document

Quality
Systems

We operate according to all quality systems applicable with the MedTech industry.

We provide our customers with market access for their products anywhere in the world.

Strong
Expertise

We provide expertise in how to apply the QMS at its’ best and most efficient way with customer’s need in focus.

We reinforce our customer’s ability to act and stay present in the global MedTech market.

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.

Innovative Solutions

Efficient Processes • Sustainable Solutions

SHL Healthcare’s Center of Excellence in Borås (Sweden) is dedicated to planning and implementing the most efficient processes with the support of carefully selected machinery. With Borås as the Swedish city of textiles, we can stay ahead when it comes to materials. We strive to provide innovative solutions with a focus on efficiency and sustainability – with the ultimate goal of being a competitive and preferred supplier.

Global Logistics

  • Manufacturing sites in Bulgaria and China
  • Warehouses in EU and Asia
  • Different delivery options

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 Centric Collaboration • Flexible services • Rapid Execution

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 rapidly execute and ensure that project requirements are identified and targets are met.