Regulatory Support

Regulatory Tune-Up, Pre-Audit, Transition, and Ad-Hoc Services

MDSAP Audit Preparation

MDSAP Audit Preparation

With MDSAP registration becoming mandatory in Canada on Jan. 1, 2019 for all medical device manufacturers and establishments registered with Health Canada, Compliance on Tap is ready to assist with making the MDSAP transition as smoothly as possible.

When a company transitions to MDSAP, it has the option to enroll for coverage of any of the other participating countries' regulatory audit requirements, i.e. FDA (USA), TGA (Australia), ANVISA (Brazil) and MHLW (Japan), so long as it is licensed by these agencies to distribute its products there.

A typical MDSAP transition preparation would consist of:
- ensuring that your QMS Registrar is approved for MDSAP (and switching to an MDSAP-approved Regsitrar if necessary)
- registering for MDSAP
- updating your QMS to ISO13485:2016 (if not already carried out)
- updating your QMS to address any additional requirements from the jurisdictions for which your MDSAP registration will apply, such as QSR, UDI, specific medical device post-market surveillance and reporting requirements, etc.
- ensuring that your medical device technical files are up-to-date and that they cover the relevant country-specific requirements
- ensuring that your company's QMS logs are current and that all open tasks have been promptly followed up, including open CAPA findings, ECO's, FCO's, Complaint Files, OFI's and issues from Management Reviews and audits
- ensuring that there are no issues with document and records controls
- ensuring that staff have been adequately trained for the upcoming MDSAP audit
- conducting an internal audit and one or more Management Reviews to asses MDSAP readiness

MDSAP transition itself consists of a preliminary document review conducted offsite by the MDSAP Registrar, followed by Stage 1 and Stage 2 audits. After a successful MDSAP transition, an MDSAP certificate is issued by the Registrar and annual surveillance audits are conducted, which are similar in scope to the ISO13485 surveillance audits but usually involve more onsite time from the Registrar. MDSAP registration follows a 3-year cycle in a manner similar to that of ISO 13485 registration & recertification.

Do not hesitate to contact us if you require assistance with preparing for any aspect of MDSAP.

European MDR Transition

European MDR Transition

The European Medical Devices Regulations will take full force in April 2020 for medical devices and on April 2022 for in-vitro diagnostic devices (IVDD). Among the changes from the existing MDD (93/42/EEC, replaced by EU 2017/745) and IVDD (98/79/EC, replaced by EU 2017/746) are:

- stricter control for new high-risk medical devices via a pre-market licensing mechanism which will involve a pool of experts at the EU level
- stricter designation and oversight of Notified Bodies
- inclusion of some aesthetic devices (which were previously exempted under MDD) within the scope of the MDR
- new risk classification system for in-vitro diagnostic devices
- a Unique Device Identification database with traceability to all medical devices
- the introduction of an "implant card" containing information about implented devices for a patient
- tighter rules on clinical evidence, along with an EU-wide procedure for authorizing clinical investigations
- increased requirements for post-market surveillance
- EU-wide coordination mechanisms for tracking vigilance and market surveillance

Compliance on Tap along with its network of professional associates stands ready to assist you with your MDR needs.

Targeted Audits

Targeted Audits

Compliance on Tap can conduct audits to target specific concerns you might have regarding your regulatory compliance or weaknesses in your system in order to strengthen your position ahead of a regulatory audit, as well as to identify root-causes for deficiencies and to make necessary corrections in response to regulatory agency findings.

Ad-Hoc Services

Ad-Hoc Services

If you require assistance with your in-house regulatory processes, an outside opinion about an issue, general guidance or preparation of specific administrative documents, do not hesitate to contact us.

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