Project
management

High-quality project planning and project management are of paramount importance in the development of medical devices. With a thorough knowledge of product lifecycle models, MERITERN contributes to reducing project risks, time-to-market and market success. Our cloud-based project management tools provide transparency anytime, anywhere.

 

  • Knowledge of the regulatory processes of product marketing authorization
  • Partnership with notified bodies, authorities, accredited test houses, clinics, research centers
  • Investigating medical adverse events and its regulatory processes
  • Production launch (NPI project management)
  • Flexible change management
  • Medical device software life cycle management (MSZ EN 62304)
  • Feedback and non-conformity management, CAPA process
  • Risk assessment processes of medical products, systems risk analysis, design and process FMEA methods (EN ISO 14971)
  • Key process indicator management

Design and
development

Whatever stage of product development you are at, MERITERN has a team of skilled professionals at your disposal to support or fully cover your design activities.

 

  • Design feasibility studies
  • Technical preparation of patents
  • Requirement management
  • Electrical, mechanical development
  • Usability engineering
  • Embedded, full stack and database management software development
  • UX/UI development (MSZ EN 60601-1-8)

 

MERITERN uses OnShape agile product design platform with cloud-native CAD & PDM saving design time due to Integrated version control and reduced IT overhead.

 

Onshape’s unique cloud-databased architecture delivers a brand-new quality of real-time CAD collaboration.

 

Collaborate anytime, anywhere, on any device. Review, comment and approve the design outputs using an intuitive platform without any kind of installation or hardware requirements even on your smartphone.

Realization process
development

From simple, customized hand tools to automated assembly and inspection workstations, whatever your demand is, MERITERN’s experienced manufacturing engineers can take it from scratch to commissioning and process validation. We develop and manufacture your concept with the production needs and the product in mind, even in clean room environments.

 

  •  Custom hand tools, devices
  • Mechatronic assembly and inspection devices integrated with software
  • Molds for low pressure and transfer technologies
  • Production technology analysis
  • Production technology transfer management and scheduling in controlled production environment, clean room

Qualification process
development

Whether the material is an input or an output of the process, we develop efficient, high-throughput and reliable processes so that high quality and user safety are not in question. In our quality process development activities, we keep the requirements of ISO 13485 and ISO 9001 quality management standards in mind and strive to exceed them wherever possible.

 

  • Metrology
  • Statistical tools for LOT acceptance, First Article Inspection (FAI)
  • Documentation and record generation system development

 

PLC automated machine vision-based qualification workstations.

Realization process
validation

Before any batch of the medical device from the process is commercially distributed, a manufacturer should have gained a high degree of assurance in the performance of the manufacturing process such that it will consistently produce products meeting requirements.

 

A successful validation program depends upon information and knowledge from product and process development. MERITERN’s dedicated team has hands-on, ready-to-use experience in a wide range of processes used in the production of medical devices.

 

  • Establishing a strategy for Process Control
  • Design of Experiment (DOE) studies
  • Process capability studies 
(Cp / Cpk, Statistical methods per ISO 16269-6, ISO 22514-6)
  • Conduct process stability studies
  • Execution and organization of validation of production processes, IQ, OQ, PQ (welding, gluing, transfer molding, packaging, distribution, EtO sterilization)
  • Establishing process monitoring strategy
  • Packaging shelf-life testing for terminally sterilized medical devices (ISO 11607-1, ISO 11607-2, ASTM F1980 – 16, ISO 2758, ASTM F2096 – 11, MSZ EN 868-5, ASTM D4332 – 14, ASTM D4169 – 16)
  • Ethylene oxide sterilization of health-care products (ISO 11135, MSZ EN 556-1, MSZ EN 1422)

Realization and
material management

Prototyping and more

 

MERITERN’s prototyping and custom manufacturing staff can help you bring your design to life, whether it’s a sketch, a fully developed part or an assembly. The focus of our realization service is to produce a product that meets all your requirements in the shortest possible time. To achieve this, we base our production activities on intensive communication and technical support.

 

Procurement and storage

  • Identification system
  • Total traceability
  • Qualification of incoming items
  • Supplier evaluation and management

 

In-house capabilities

  • Metal and polymer machining
  • Casted silicone rubber, polyurethane, epoxy and composite parts
  • RTV and transfer silicone molding
  • Machined and sintered ceramic parts
  • FDM, SLA additive manufacturing
  • Assembly technology, gluing
  • Electrical discharge machining
  • Wiring of electrical units
  • Outsourced capabilities

 

PCBs and PCBAs

  • Sheet metal processing
  • Composite structures
  • Injection molding
  • LASER cutting, welding and marking
  • Water cutting
  • Aluminum casting

Design verification,
preclinical studies

  • Biological evaluation of medical devices (ISO 10993-5,
    ISO 10993-10, 10993-12) cytotoxicity, irritation and skin sensitization
  • Usability verification process, formative usability evaluation
    (MSZ EN 60601-1-6, MSZ EN 62366-1)
  • Basic safety and essential performance of medical devices
    (MSZ EN 60601-1)
  • Medical devices related electromagnetic disturbances
    (EN 60601-1-2)

Design
validation

  • Technical support of clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155)
  • Usability validation process, summative usability evaluation (MSZ EN 60601-1-6, MSZ EN 62366-1)

Technical service,
consultation, quality
system engineering

Whether it is a new product/process or a well-established one, MERITERN’s experts will help you develop benefit-risk-oriented quality management procedures taking into account the objectives that really matter to you.

 

  • Standard operation procedures in compliance with ISO 9001:2015 and / or ISO 13485
  • Medical Device Single Audit Program (MDSAP)
  • Conformity assessment procedure (COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 (MDD), REGULATION (EU) 2017_745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL (MDR))
  • Product after sales support, document, and record retention

Important projects that helped us build our competence

DO YOU HAVE ANY QUESTION?
Send us a message