COMPLIANCE BUILT IN – CONTROLLED SUPPLIER INPUTS
We operate ISO 13485:2016 certified Quality Management Systems at both our manufacturing sites in our China site and our EU site (Bulgaria).
Both sites operate under harmonized Quality Management Systems, adapted to local regulatory requirements while maintaining consistent global quality principles, processes, and control.
Our QMS is also aligned with 21 CFR Part 820 and EU MDR MDR 2017/745.
In addition, our China operations are compliant with applicable regulatory requirements for Japan and South Korea, including MHLW Ministerial Ordinance No. 169 and GMP requirements from Ministry of Food and Drug Safety, supporting regulatory expectations in these markets.
MARKET AWARENESS
MARKET TRENDS • REGULATORY SURVEILLANCE • INDUSTRY EVENTS
By maintaining strong market awareness, SHL Healthcare ensures that products are developed in line with evolving customer and regulatory requirements. We actively monitor global regulatory changes and participate in key conferences and tradeshows, allowing us to anticipate market needs. These insights enable us to guide our customers in designing products that are compliant, competitive, and aligned with local and international standards.
TRUSTWORTHY QUALITY
RIGOROUS QUALITY ASSURANCE
We operate in full compliance with all quality systems relevant to the MedTech industry, enabling our customers to achieve global market access for their products.
CONTRACT MANUFACTURING
DEFINED RESPONSIBILITY MODELS – CONTROLLED EXECUTION
We operate as a contract manufacturer with clearly defined responsibilities between Legal Manufacturer and SHL Healthcare.
This ensures transparent interfaces, controlled execution, and reliable production output aligned with regulatory expectations and customer requirements.
GLOBAL OPERATIONS
GLOBAL SITE ALIGNMENT – CONSISTENT QUALITY OUTPUT
Our manufacturing operations in Europe and Asia are harmonized through standardized processes and integrated quality systems.
This enables scalable production while maintaining consistent compliance and product quality across regions.
REGULATORY SUPPORT
FROM REQUIREMENT TO SUBMISSION – SUPPORTED REGULATORY PATHWAYS
We support customers throughout the regulatory journey – from early development and design transfer to submission and approval.
Our teams contribute with documentation, structured input, and regulatory alignment to support efficient market access.
EXPERINCE & TRACK RECORD
DECADES OF CONTRACT EXPERIENCE • PROVEN IN REGULATED MARKETS
With over 30 years of experience, SHL Healthcare has built a strong track record in regulated medical device manufacturing.
We are committed to consistent quality delivery, stable operations, and long-term compliance supported by successful audits and continuous improvement.