What M-TEC Do?

M-TEC Medical Technology Ltd. has gained a wealth of experience over the last 30+ years in different parts of the world in connection with the mass production of standard Disposable Syringes, Auto Disable syringes for fixed dose immunization purposes, RUP (re-use prevention feature) syringes, Syringes with SIP (sharp injury protection) features, Safety needles, IV Catheter, IV Infusion Set, Scalp Vein Set, Blood Transfusion Set, Burette Set, Urine Collection Bag, Oral Dispenser, Feeding Tube, Wound drain tube, Suction catheter, Surgical suture and others medical devices where employing the latest state of the art of equipment.

M-TEC has the experience necessary in order to guide the clients towards the most effective production methods and profitable products taking into consideration prevailing circumstances.

Services (including more than listed).

  • Selection of Medical Device manufacturing technology
  • Evaluation of product quantity, sizes, product diversity
  • Consultancy of product diversity with investor / engineers
  • Product design with investor team / engineers on side
  • Selection of machinery, equipment, machine sourcing, QC, MB equipment etc.
  • Factory layout design and drawing finalization
  • Pre-inspection for construction of manufacturing areas
  • Supply of design drawings for standard and Auto-Disable (AD) syringes for fixed dose immunization, RUP syringes and syringes with SIP feature, Safety Needles, IV Catheter, IV Infusion Set etc.
  • Prepare of product master file (PMF)
  • Assistance in start-up and accompaniment during production runs
  • Technology transfer of medical device manufacturing know-how with focus less plastic designs
  • Selection of medical device manufacturing technology
  • Planning and engineering for new medical device production lines
  • Sterilization process validation of ETO and E-Beam process
  • Assistance and guidance for WHO PQS certification process
  • Evaluation of clean room facilities in accordance with GMP guidelines for medical devices
  • Machine installation, commissioning, validation and QMS documentation
  • Evaluation of the physical Quality Control process of medical devices in whole manufacturing process

QMS Documentation to run the factory

  • Prepare written procedures for Production operation and training of employees
  • Prepare written procedures for Engineering, QA, QC, Microbiology and Training
  • Prepare written procedures for Warehouse, Supply chain, Human Resource, Sales & Marketing and training
  • QMS documentation for ISO 9001:2015, ISO 13485:2016 certification process
  • QMS documentation for WHO PQS certification
  • QMS documentation for CE certification process
  • Development of quality management system
  • Preparation of quality manual and site master file.
  • Supervision of equipment and production during production
  • Technical Support and trainings during running the factory

Experience in R&D Activities

medical safety devices

Research & development of medical safety devices like K1 AD Syringe, K4 safety needle, intradermal delivery safety device, needle free device recon plus K11, safety catheters

tiny safety syringe

Research and development of tiny safety syringe 0.5ml AD & EA for immunisation purposes

special Disposable

Research and development of special Disposable and AD syringes with reduced weight in harmony with ISO Standards.

silicone free gaskets

Research and development of silicone free gaskets

Project Highlights (Past 30 Years)

Commissioning, Training & Consultancy: Disposable & AD Syringe Factories

  • Indonesia (Igar Jaya)
  • Czech Republic (Czech Republic) (CSSR era)
  • Russia (Jelez) - Medizinski Abarudivania
  • Bangladesh (JMI)
  • Indonesia (PT Oneject)
  • Pakistan (Amson)
  • Saudi Arabia (Al-Shifa)
  • India (HMD)
  • Nigeria (Afrimedical) (Freelance with own company)
Committed to providing innovative medical solutions worldwide.

M-TEC Team

Key Personnel of M-TEC

  • 30+ years experience in engineering, consultancy for project planning up to implementation of a medical device factory.
  • Disposable, AD & RUP syringes factories first employed and later freelance consultancy with own company
  • Technical expert on K1 Auto Disable Syringe & K4 Safety Needle 
  • Vast knowledge on ISO 13485:2016, CE Certification & WHO PQS certification process

Mr. Norbert Rudolf

Chairman

Mr. Saleh Ahmed

Technical Director

Technical Director

Former General Manager and Head of Product Development, JMI Group, Bangladesh

  • 18+ years working experience in Pharmaceuticals and Medical Devices Industry.
  • Technical expert in project planning, product development and operation 
  • Vast knowledge on material and machine sourcing for Medical Device manufacturing industry 
  • Experienced in International business of Pharmaceuticals and Medical Devices
  • Expert on ISO 9001: 2015, ISO 13485:2016, CE certification & WHO PQS certification process
QA Manager

Former Head of QA of ANC Medical Devices Ltd. Bangladesh and QC & Product Development In-Charge, JMI Group, Bangladesh

  • 15+ years working experience on Syringe and other Medical devices manufacturing process Product Development, Quality Assurance, Quality Control 
  • Sound knowledge and experience on QMS, Documentation, GDP, GMP, Product Design & Development, MDF/DMF, Technical File
  • Expert on Cleanroom validation, Source Evaluation, Process and Equipment Validation, ETO and E-Beam Sterilization process validation
  • Experienced on ISO 9001:2015, ISO 13485:2016, CE Certification & WHO PQS certification process 

Mr. Ripon Chandra Paul

QA Manager

M-TEC Medical Technology Ltd.

 Some Pictures of M-TEC Team with Afrimedical 

Project 01
Project 03
Project 02
Project 04

Contact Us

We will answer any questions you may have about our rights or partnership service right here.

M-TEC Medical Technology Ltd.

Register Office

Tepeleniou 13, TEPELENIO COURT, Floor 2, 8010, Paphos, Cyprus

Germany Address:

Postcode: 24534 Neumuenster, Postbox 2307, Germany

TeL & Whatsapp

+49 1622111156,
+880 1711 944736,
+880 1714297770

EMAIL

m-tec@shtm.de
medical-technology-service@shtm.de

Website

https://m-tec-medical-technology.com/