Certificates
Lapa Master Industry has obtained a comprehensive range of certifications, demonstrating its commitment to quality, safety, and regulatory compliance. Here's of each certification: Quality Management Systems, These certifications demonstrate Lapa Master Industry's commitment to delivering high-quality products, ensuring customer satisfaction, and complying with regulatory requirements for Surgical instruments and Dental instruments. QUALITY: 100% Satisfaction Guaranteed All our Instruments are produced with high quality stainless steel and are thoroughly checked and inspected during all phases of production, In order to ensure that they correspond to the international standards laid down by the certifications.
| Membership Certificate The Sialkot Chamber of Commerce & Industry. | Membership Certificate The Surgical Instruments Manufacturers Association of Pakistan. |
Membership: A-30972 | Membership: L073 |
| Free Sale Certificate. | CE CE Mark |
Office of District Health Officer Sialkot, | EUDAMED - European Database on Medical Devices, Manufacturer, PK-MF-000046089, LAPA MASTER INDUSTRY - Sialkot, Pakistan. |
| ISO 9001:2015 : Quality Management. | ISO 13485:2016 : Quality Management. |
ISO 9001:2015: Certification for Quality Management Systems, ensuring customer satisfaction and continuous improvement. | ISO 13485:2016: Certification for Medical Devices - Quality Management Systems, ensuring compliance with regulatory requirements. |
| ISO 7376:2020 : Quality Management. | ISO 50001:2015 : Energy Management. |
ISO 7376:2020: Certification for Sterile Hypodermic Needles, ensuring compliance with international standards. | ISO 50001:2015: Certification for Energy Management Systems, ensuring efficient energy use and reduction of environmental impact. |
| ISO 14971:2019: Risk Management. | IEC 60601-1:2015: Electrical Safety. |
ISO 14971:2019: Certification for Medical Devices - Application of Risk Management, ensuring identification and mitigation of risks. | Electrical Safety: IEC 60601-1:2015: Certification for Medical Electrical Equipment, ensuring safety and performance. |
| EN 10088-1:2023 : Material Specifications. | ISO 7153-1:2016: Surgical instruments - Metallic materials - Part 1 certification. |
Material Specifications: EN 10088-1:2005: Certification for Stainless Steels, ensuring compliance with European standards. | ISO 7153-1:2016: Surgical instruments - Metallic materials - Part 1 certification. |
| Good Manufacturing Practice (GMP) | Certificate Incorporation in SECP | |
| GMP Certificate: Certification for Good Manufacturing Practice, ensuring compliance with regulatory requirements for pharmaceutical and medical device manufacturing. | The Securities and Exchange Commission of Pakistan, | |
| ISO 10993-1:2018: Certification for Biological Evaluation of Medical Devices, Ensuring Safety and Biocompatibility. | Lapa Master industry Biocompatibility Testing from PCSIR |
This is to certify that Lapa Master Industry, owned by Muhammad Iqbal, has successfully passed Biocompatibility tests for their Laryngoscope Set Surgical Instruments, as per the requirements of ISO 10993.
Biocompatibility Tests Conducted:
1. Cytotoxicity Test (ISO 10993-5): Evaluates the Potential of the Device to cause cellular Damage.
2. Skin Sensitization Study (ISO 10993-10): Assesses the Device's Potential to cause allergic reactions.
3. Acute Irritation/Intracutaneous Reactivity in Rabbit (ISO 10993-10): Evaluates the Device's potential to cause Skin irritation.
4. Material-Mediated Pyrogenicity (ISO 10993-11): Assesses the device's potential to cause fever.
5. Systemic Toxicity (Acute) ISO 10993-11: Evaluates the Device's potential to cause systemic toxicity.
6. Hemocompatibility (ISO 10993-14): Assesses the Device's Potential to cause Adverse Reactions with Blood.
Test Results:
Lapa Master Industry's Laryngoscope Set Surgical Instruments have successfully passed all the biocompatibility tests, demonstrating:
1. Non-Cytotoxic: The Device did not show any Cytotoxic effects.
2. Non-Sensitizing: The Device did not cause any allergic reactions.
3. Non-Irritant: The Device did not cause any skin irritation.
4. Non-Pyrogenic: The Device did not cause any fever.
5. Non-Systemically Toxic: The Device did not show any systemic toxicity.
6. Hemocompatible: The Device did not cause any adverse reactions with Blood.
Certification:
This certification is issued by PCSIR (Pakistan Council of Scientific and Industrial Research), confirming that Lapa Master Industry's Laryngoscope Set Surgical Instruments meet the requirements of ISO 10993 for biocompatibility.
Validity: This certification is valid for [insert validity period], subject to periodic audits and testing to ensure ongoing compliance with ISO 10993.
ANALYTICAL/ TEST REPORT
In respect of: M/s. Lapa Master Industry in Sialkot, Pakistan.
Sample Received from: Representative Mr. MUHAMMAD IQBAL
Name of the Sample: Laryngoscopes
Type/Grade of the Material: AISI-304 Stainless Steel
Hardness: HRB 77 - 80 Rockwell (Average)
The Medical Device is Made of AISI 304 Stainless Steel.