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Specific development

SGH Medical Pharma guides the development of your medical devices with precision, compliance, and agility. From early design to final product release, we combine engineering expertise and regulatory knowledge to turn your needs into robust, market-ready solutions — personalized, compliant, and scalable.
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Medical device refers to every consumable or system used in the human and veterinary health: for diagnostic, packaging, Life Sciences, pharma and many other industries,…

Understanding Your Needs: Turning your requirements into structured innovation

Whether you are launching a new device, adapting an existing design for large-scale production, or seeking support with regulatory documentation or manufacturing processes, SGH anticipates and translates your requirements into actionable project stages. We align each phase with your timeline and compliance obligations, ensuring product viability and operational success.

Our Medical Devices specific Development Process

Aligning your vision with technical feasibility and combining creativity and compliance

 

  • Assessing your need, market context, and inteded use of the medical device
  • Conducting concepts mapping
  • Elaborating multi-criteria evaluation matrices to ensure viable planning from day one (a book of concepts can be produced in this phase)

 

Our engineers structure the device’s architecture with a focus on performance, usability, as well as manufacturing and assembly technics. We create 3D printing, IP screening, and early sketches.

Illustration of step 1 in custom medical devices, showcasing creativity

Ensuring Technical and Financial Viability

 

The costing phase is a vital part of ensuring the success of a custom medical device project.

  • Carefully analyzing all production-related costs, including tooling and mold design (e.g. injection molding, extrusion blow molding and injection blow molding), finishing operations, sourcing, assembly and packaging
  • Incorporation of specific processes such as sterilization, welding or adhesive bonding, as well as robotics, automation and control requirements

 

This rigorous approach enables us to provide our clients with a clear understanding of the technical and financial viability of their project, while ensuring the quality and compliance required in their sector.

Illustration of step 2 in custom medical devices, showcasing costing process

Building and iterating fast

 

The design phase allows SGH Medical Pharma to transform the economic study into a concrete and structured project.

  • Producing the design documentation and User Requirements Specifications (URS) for the product and equipment
  • Using our 2D and 3D CAD tools, simulations, rheology analyses, and prototyping to validate technical feasibility and optimize every detail before industrialization
  • Application of the ISO GPS dimensioning standards to ensure common understanding for dimensional accuracy and reliability of parts

 

This approach guarantees our customers plastic solutions that are perfectly adapted to pharmaceutical and medical requirements, while respecting the constraints defined during costing.

Illustration of step 3 in custom medical devices, showcasing conception

Preparing for scalable and cost-effective production

 

We turn the approved design into a robust, controlled manufacturing process.

  • Internally carrying out feasibility studies for molds and processes.
  • Implementing quality procedures, such as Design Qualification (DQ), as well as carrying out risk analyses via PFMEA and DFMEA
  • Defining and implementing the necessary qualification protocols to ensure regulatory compliance and establish in-process control (IPC) criteria to secure production.

 

This rigorous approach guarantees reliable industrialization and ensures that our customers receive compliant, repeatable manufacturing that meets pharmaceutical and medical industry standards.

Illustration of step 4 in custom medical devices, showcasing industrialization

Securing Reliability Before Series Production

 

SGH Medical Pharma does the adjustment thus verification phases to ensure that the medical device and its production process fully comply with the requirements.

  • Carrying out metrology checks, as well as functional and performance tests.
  • Carrying out design and assembly checks in accordance with the established URS.
  • Verifying the assembly and submitting initial samples after OQ

 

This step guarantees the device’s reliability and compliance before it goes into series production, ensuring that our customers’ expectations are met.

Illustration of step 5 in custom medical devices, showcasing adjustments and verification

Validating Processes for Compliance and Reliability

 

At SGH Medical Pharma, all our molds are qualified according to ISO 13485, whether they are for medical devices or not such as primary packaging, enabling us to guarantee our customers robust qualification processes.

  • Drafting the necessary protocols and implement all qualifications: Design Qualification and protocols resulting from industrialization, Factory Acceptance Test, Site Acceptance Test and Installation Qualification, as well as Operational Qualification and Performance Qualification

 

This methodical approach guarantees regulatory compliance, process robustness, and production repeatability, ensuring our customers optimal reliability and safe market launch of their devices.

Illustration of step 6 in custom medical devices, showcasing qualification process

Production

 

  • With in-house expertise in customized medical devices manufacturing, SGH Medical Pharma ensures production continuity and control across sites in Europe and Tunisia.
Illustration of step 7 in custom medical devices, showcasing transfer to production

Quality and regulatory affairs support alongside the specific development process

At SGH Medical Pharma, quality and regulatory affairs are integral to every stage of medical device development. Our teams constantly monitor standards and regulations to ensure compliance with international standards. We carry out biocompatibility tests (BRA and TRA), human-factor engineering, part metrology and stability studies to ensure product safety from the design stage onwards. We also handle artwork design, Regulatory Technical File compilation and the preparation of documents required for CE marking and FDA registration. This integration of quality and regulatory compliance throughout the process guarantees our customers a reliable, controlled market launch that meets the pharmaceutical and medical sectors’ most stringent requirements.

SGH Medical Pharma transforms your medical device ideas into compliant, market-ready products — from concept to manufacturing, with full regulatory alignment.

From Design to Manufacturing: A Sustainable Solution

Thanks to vertically integrated capabilities — plastic injection, assembly lines and assembly workshops, including electro-medical devices specific environment, cleanrooms —. As contract manufacturer, SGH Medical Pharma ensures consistency from the design phase to industrial ramp-up.

Personalized and Customized Medical Devices with an expert Team

When patient-centric design matters, SGH adapts to your medical, pharmaceutical and IVD needs. We develop personalized medical devices based on custom specifications, integrating traceability and MDR alignment from day one.

 

Every project at SGH is managed by a dedicated project manager and supported by a multidisciplinary team, including a development quality manager. From early concept to industrialization, we guide you through feasibility, design, prototyping, and regulatory documentation — ensuring a compliant, fully industrialized medical device.

 

This flexibility makes us a trusted contract manufacturer for companies seeking individualized healthcare solutions.