regulatory approvals
With a quality policy objective of customer satisfaction, Best Medical Canada is committed to establishing and maintaining acceptable levels of measurable quality in its production and services and maintains quality standards that meet or exceed the requirements of a number of regulatory bodies. Accordingly, Best Medical Canada has adopted a quality policy of: "continuous quality improvement aimed at maintaining high levels of customer satisfaction and product quality".
ISO certification
| ISO CERTIFICATION | SCOPE | |
| Directive 93/42/EEC Annex II (excluding Section 4) DOWNLOAD CERTIFICATE - PDF |
Patient Dose Verification System; Irradiator Dosimetry System; Dose Reporter Software | CE 0120 |
| ISO 13485:2003 (UKAS accredited) DOWNLOAD CERTIFICATE - PDF |
Design and manufacture of Radiation Dosimetry Systems for medical applications | |
| ISO 13485:2003 (SCC accredited under CMDCAS) DOWNLOAD CERTIFICATE - PDF |
Design and manufacture of Patient Dose Verification Systems (including software) | CMDCAS - Canadian Medical Devices Regulations |
| ISO 9001:2000 (UKAS accredited) DOWNLOAD CERTIFICATE - PDF |
Design and manufacture of radiation and radon detection systems. Distribution of Radiotherapy related seeds, ribbons, implant needles/tubes, fiducial markers, QA electrometers and phantoms, patient positioning equipment, block cutters, refurbished CT & X-Ray equipment, and other related Radiotherapy accessories. |
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website links for regulatory approvals
- SGS
List of Certifications issued by SGS
Search -Certified clients
- FDA
510(k)'s issued to Thomson Nielsen
Search -Medical devices, 510(k)
- HEALTH CANADA Therapeutic Products Directorate
Medical Device Product Licenses issued
Search -Medical device