Our Services
Medical device companies turn to Spierings for full product lifecycle solutions for delivering high-quality, critical products to global markets.
Engineering Expertise
We offer more than 30 years of experience in medical device development and manufacturing of class I, II and III devices. Strong in metal and biomaterials.
FDA & MDR Certification
Regulatory expertise for all medical devices class I, II and III. FDA and the Medical Device Regulation are part of our daily business
ISO 13485 Specialists
Since 1992 we are building and continuously improving our quality management system guided by our unique software to enable the most strong and efficient quality control of our medical devices
Product Development
- Prototyping
- Product Design
- Mechanical Engineering
- Animal tissue
- Absorbable devices
- Surgical Instruments
- Implants
Validation Studies
- Sterile Packaging
- Lifetime testing
- Effectiveness testing
- Sterilezation dose
- Bioburden
- Verification of design requierements
- Clinical evaluation
Quality Management
- ISO 13485
- Technical files
- Process Manufacturing
- Process Design and Development
- Traceability
- Risk Management
- Complaints and deviations
Certification & Legislation
- MDR & FDA
- Class 1 till 3
- Release to market worldwide
- Global distribution
- Medical device legislation
- Donor tissue legislation
- Electrical machine legislation
Advantages
Speed & Manufacturing
Extensive experience in biomaterials and mechanical systems including high-level assembly and finishing makes Spierings the ideal partner for speeding up your process and completing manufacturing dead lines. Spierings controls all finishing of goods in-house.
Certified & Qualified
FDA-registered and ISO 13485 certified unsures operating according current standards and legislations enabling a controlled and assureed development process and market accessible product file.
All Expertise In-house
A proven track record of 30 years on the market in a broad range of Class II and Class III medical devices. Spierings has a team of highly skilled people with multiple university degrees safeguarding the knowledge for a fast and perfect product development cycle.